February 14, 2023 • 46 mins
I interview Dr. Martin Tolar , Founder, CEO and President of Alzheon on the Phase 3 trail going on right now, that will bring this drug up for FDA approval. We discuss how exercise, lifestyle and fasting can clear the brain, who will pay for breakthrough medications and how you can take your longevity into your hands and advocate for prevention of brain decline in our health system and in your own lifestyle. Let’s kick Alzheimer’s to the curb.
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Episode Transcript
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(00:08):
When I look in the mirror,I don't see wrinkles. When I look
in the mirror, I see hairon my head, not my shoulder.
Hello. Hello, Hello, Thisis Adrian Bergen. This is Generation Bowl,
the fountain of truth, the fountainof truth about what well, the
(00:31):
fountain of truth about aging. Andwe're going to get right to it right
now because we have a very specialguest and he's not been a guest for
the first time today. We arereally following in his footsteps over the past
year or more when he was onand as I said to him off the
air, you've been busy. Andwho is he. He's Martin Toler,
Doctor Martin Toler. He's the founder, he's the president, he's the CEO
(00:55):
of al Zeon, and he ishere with a gift, a gift for
all of us of peace of mind, the potential, the potential that in
the future Alzheimer's will not be aword that Zack kids will know. We
know it, and it is abarrier, I can tell you. It
stands in the way of all ofour peace of mind with regard to aging.
(01:19):
Many people feel that they are moreafraid of living with Alzheimer's than passing
away. As a lawyer in thefield, I can tell you that these
ideas are very popular today. Peopleare making special powers of attorney so that
they don't have to live through anAlzheimer's lifestyle. This is a terrible,
(01:45):
terrible scourge, also very expensive.So when I say that doctor Toller is
a hero, he's going through thehero's journey and he has made some wonderful
progress you want to hear about,Martin. Thank you so much for being
with us today. Thanks so much, Adres and for such kind words.
Well, it is true on theradio, you know. I know that
(02:07):
Joe's scientists, people like you,people who are in the field, they
go through this day to day.They don't even have time to pick up
their head to see what they're doingand where they are in life half the
time. So I think it's it'sonly right to say things like this,
Now, what are you doing?Tell us about the little, a little
and the big aspects of your newbreakthrough. So the breakthrough it's not only
(02:31):
at Alzayon, but also at thewhole field of Alzheimer's. The so just
kind of a little bit of history. So this is our fourth company.
Was this team we have been onthis for a couple of decades. Founded
Alsayon about ten years ago now almostten years ago, and the our goal
(02:53):
at Alsayon has been first to solvethe scientific puzzle, meaning what is causing
the dizzy and that has been themajor barrier for success in treating the disease.
And we really uncover the puzzle.We were able to solve you know,
what is the toxic agent, howto go about it, and so
forth. And now our data butalso data from the other programs UM that
(03:16):
we're going to talk about, haveconfirmed that this is this is really the
solution and this is the approach thatcan help patients, which really has been
the major, major, major breakthrough. So we we know that at least
one path to alleviating the disease andpotentially also preventing it, as you mentioned
earlier, has has been has beenyou know solved. UM. Now the
(03:40):
our breakthrough has been so we reporteddata from our face to study Face to
be studied which showed very profound effectof our drug on both the buy markers
of the Alzheimer's disease some of thethe ways we can assess the brain damage.
Again, there was superior to theother approaches with the antibodies. We
(04:04):
also show that we can slow brainatrophy in particular the hippocampal atrophy again uh
superior to the to the effect ofthe antibodies. And finally, we have
shown that we can stabilize the cognitionin the patients who are in the terminal
stage of the disease, meaning thechlinical stage of the disease. So that
has been m kind of on ourend. We reported both six and twelve
(04:27):
months data from that study. Wealso completed enrollment in our Faith three,
so we will have the data thatwe believe will help us register the treatment
so it can get to the patientsin the middle of next year. And
finally, the breakthroughs in the inthe broder Alzheimer's field has been There were
two drugs that have been approved bythe FDA UM and only the most recent
(04:54):
one drug called thecanomat from EASTI,showed very convincing again that the approach to
targeting what we call the toxic solubleaneloid. Again the science that Alsion Bill
and written the papers about and hasbeen all confirmed. So we want you
to know as you're listening why doctorTeller is on top of the entire field
(05:15):
because he serves on business and scientificboards that deal with Alzheimer's neuroscience. He's
been a professor at the Yale UniversitySchool of Medicine. I don't have to
give you all these credentials because it'sa short show, but one of those
boards is the Drug Discovery Foundation andthe Alzheimer's Foundation and Advanced Healthcare Management Institute.
(05:35):
So with all of this background,I do know that on an emotional
level, your real target is prevention. And you have said that the new
growth in biomarkers, being under ableto understand parts of our own body and
have their functioning goes hand in hand. We usually look at doctor Teller at
(05:57):
biomarkers from a biohacker point of view, Did I gain weight? You know
what's my blood pressure? Ha's myheart rate? And then more sophisticated looking
at you know what's my cell healthof mito country. We talk about this
on the show all the time,but you're looking at it in a little
bit different way, and that ispart of preventive health, particularly with regard
(06:20):
to Alzheimer's. Can you tell usa little bit about that now, So
I'll start with the course of theAlzheimer's disease. So it's very important to
understand that what we call Alzheimer's isthe terminal stage, the clinical stage where
patients have clinical symptoms, they starthaving memory problems, and that it progresses
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in few years to death of thesepatients. That's really the very final again,
the terminal stage. The real majorityof the disease is the first twenty
or twenty five years of the diseasewhere there's accumulating injury of the brain.
And this starts in the fifties,you know, even in the forties,
depending on how what's your genetic backgroundand so forth, And this is the
(07:05):
time where we can intervene, andwe should intervene, and and our treatment
that it's oral, that has afavorable safety and that can be administered for
literally for the rest of the lifeor for decades, UH is suitable for
this. And that's ultimately, asyou said, Ran, that's that's our
(07:26):
goal, m because again you youwe have an opportunity with understanding the biology
and the science behind the Alzheimer's disease, number one, using the biomarkers to
find the patients, and number twoto treat them. Before they have the
chinical symptoms. Now, the diagnosishas been absolutely essential for our success and
success of the other companies because nowwe know how to find the patients not
(07:49):
only very you know, with ahigh degree of accuracy when they have the
symptoms, but also before they havethe symptoms. That's called the biog from
definition of Alzheimer's and what it alsoshowed, and there have been a number
of papers now published that you know, we thought the number of people used
it was forty fifty million people onthe planet that they have the disease.
(08:11):
If you look at it from thebiological definition, it's over four hundred million.
People's actually fine a million. Sothat's the that's the number of patients
that really need this treatment. Andagain that could be held primarily in the
preventative it was the preventative fashion.Well, we come back. We're going
to pull a little bit of adifferent side of doctor Martin Toler, and
(08:33):
that is his business side. We'regoing to talk about getting to market because
that's really ultimately what we care about. We want that the pill, we
want to be able to understand it, and we want it to be safe
for us. So we will betalking about that in the context of his
Phase three trial. And then I'mgoing to tell you a story, and
that story is, well, I'mgoing to tell it to you in a
(08:56):
funny way, but it wasn't sofunny for me. Don't you guys,
go anywhere. We will be rightback. But that doesn't bother me,
not because I am happy and I'minappropriate for my aged da You may think
(09:18):
that I'm all doesn't bother me,not even because I am happy and I'm
inappropriate. Oh my, and hello, hello, Hello, once again,
This is Adrian Bergen. This isGeneration Bold, the Fountain of Truth.
(09:39):
I know that you're riveted to thisbecause I know that Alzheimer's is really the
thing that all surveys, all gerontologicalsurveys, gerontology surveys show is the most
fearful thing, even greater than theend of life for the older adult.
(10:00):
But we've just heard from doctor MartinToller, who is the founder, the
president and the CEO of Alcon,that it's not only the older adult,
that this is something that can bedetected, diagnosed lingers and begins in the
body in the forties, maybe evenyounger, certainly in the fifties and therefore
the research go toward prevention. Nowbefore we go and talk about how this
(10:24):
is going to happen, because we'rereally talking about delivering your future to you
when we deal with this question.I do have one important announcement that is
thrilling to me. I've been namedthe United Nations representative from the International Federation
of Aging. The International Federation ofAging IFA is something you could look at
(10:46):
online at IFA dot org. Youwill see that it is a conglomeration of
everybody who's fighting on every platform forbetter aging worldwide. And I'm thrilled to
be able to do this podcast inthe summer from Bangkok from the floor of
their major convention and conference. Andi have a new podcast which is launching
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tomorrow. It's called On the Ground. I'm now the podcaster for the United
Nations Global Communications Committee. And whatare we communicating. We're communicating what's working
in the world of civil society andin the world of nonprofits. So we're
sick and tired of complaining that wecan't get anything done, that the world
(11:33):
is going to hell in a handbasket, and instead we're telling you what is
working in a way that you cantake it and make it your own in
your organizations wherever you may be volunteeringor even in your corporation. We will
provide you what I call a heatmap to look around your own organization and
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see what's working and concentrate on thatinstead of always focusing on what's not okay.
So exciting times for change, andof course when we speak to doctor
Tyler, we're talking about change Phasethree. Phase three is something that is
the beginning of getting these breakthroughs tous. Explain that process to us and
(12:18):
what's happening with regard to your particularphase three trials. So phase three is
the last stage of drug development.The process usually takes, you know,
from the initial idea to completion andthe average fourteen years, but this is
the last you knows a few yearswhen you when you really have to confirm
(12:41):
in the large group of patients thatthe dark works and get all the attributes.
Then you can then bring to theregulators and ask them for approval,
because the approval really means that theyhave to you have to find you know,
uh, you have to really bringthe information regarding the safety, the
efficacy and performance of these treatments andreally have sufficient number of patients that show
(13:07):
that you're confident in the in thein these data. So that's the phase
three. We have completed the enrollmentin our phase three, and that means
that we're just following the patients inthe trial and we will have the data
in the middle of next year,and we're hoping to ask for the what's
called new dark application, the approvalthe FAM later next year. Well,
(13:31):
congratulations and of course godspeed on thatone. But I'm worried about two things.
Let's start with number one. TheFDA is not known for proving preventions
now to the extent that there's amaintenance of cognition. In other words,
things won't get worse with somebody whoalready has in Alzheimer's diagnosis. What you're
(13:56):
doing is perhaps a shoe in withregard to the FDA, because some people
call the NIA the National Institute onAging the National Institute on Alzheimer's, because
it gives ninety percent of its moneyit spends it because Alzheimer's is such a
scourge. But you and I arevery focused on prevention, and you just
(14:18):
laid out to us beautifully the possibilityof using early diagnostics and not an offering
medication offering treatment to people before anofficial diagnosis of Alzheimer's, which is what
we all really want. What doyou think of the FDA's position there,
and can you show the same thingthrough a phase three trial for both applications
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of this breakthrough. So we're ourcurrent phase three trial is in patient in
the terminal station. It means theclinical station in the early early clinical stage.
And the reason is that to seekapproval, we was the current standards
and the current evaluation and the scaleswe need to do the evaluation in the
(15:07):
patients who are to have the disease. And so these you know, scales
have been already approved and accepted bythe FDA. Now, the biomarkers that
you highlighted are going to be incrediblyuseful and important, and the data that
we already have for running a trialin the prevention, so that then you
will find the patients based on theirplasma biomarkers. Now we can do these
(15:31):
diagnoses from plasma and and and Ireally follow them. And once you know
you make the connection between the biomarkersand the clinical performance, you can say,
you know, I have stopped thisevidence of the brain destruction which is
the petile for instance, that wehave seen very robust effect on. And
then you know, as for approvalfor the prevention. So the first step
(15:52):
always is that you need to goto the disease population um. But again
everybody understands, really the majority ofthe patients, really eighty ninety percent of
the patients are in that what doyou call the pre symptomatic stage, because
again, the way the disease evolvesis that there are you know, destruction
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of the brain, tissue, ofthe neurons, the brain cells, and
at the point where the brain cannotcompensate because the brain has a high ability
to compensate by what's called the plasticity. That means the other parts of the
brain can take over the function ofthe destroyed parts of the brain. But
at some point the whole system collapses, and that's when you know you have
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the chronical symptoms. So we wantto go to that stage, you know,
way before that decase, before that. Yeah, to use a metaphor
that I've heard, if you havea four legged stool and one leg is
not doing very well, but it'sa fairly new stool, people haven't set
on it much. I won't falldown by the time, lots of people
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have said, on that stool,the other three legs can't compensate for the
weak one, and so the wholestool falls apart. But at the beginning,
you didn't know that, you didn'teven know you had a weak one
leg there because it was functioning.It was working. So if I can
use that homade metaphor, you canunderstand what we mean here by prevention.
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It's not that you're taking somebody withno symptoms and you're giving them a pill,
like we might all be taking avitamin even though we may not need
it. We think, well,can't hurt. It's not that kind of
thing. So this is something wherethey're going to have to be able to
show that they have clear clinical proofthat this diagnostic creates a pre Alzheimer's condition,
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like we have heard pre diabetes.The only drug that's really so far
been FDA approved for people who letus call them totally healthy, are statins.
I never understood how that got through. I'm only happy they do.
But it is for prevention, purelyprevention for hard issues, even for people
that don't even have hard issues.But this is a different poll game,
(18:00):
and I'm a little briskly about that, doctor Teller. I don't know why
we have to run through so muchhoops for prevention, but as you just
outlined, as we do, Iwant to tell you my second concern.
I promise everybody I would tell alittle story, and I'm going to hold
it off for our next segment.But I'm gonna end this one by asking
you how long is Phase three?When do you think you'll be completed with
(18:25):
this and making your applications? Sothe Phase three takes or our Phase three
US projected for about three years duration, but we have completed the first part
of it, which means finding theright patients, which is always the most
challenging, and now we just completingthe follow up, which is a year
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and a half in those patients thathave been already enrolled. So we completed
the enrollment last year, which hasbeen big success because it's been in the
midst of the pandemic and it's beena huge excitement around the program, again
probably given by the fact that howwell differentiated our treatment is um so were
having enrolled to study, you know, ahead of timelines, and even it's
(19:06):
a larger number of subjects. Butnow we're waiting again to follow up which
the year and a half. Soby middle of next year we will have
the data the readoubt. Okay,so now I'm going to take a little
bit of a break. We'll comeright back. And I want to pose
through a story, a personal storyof mine, an agist aspect of how
(19:26):
the medical profession looks at Alzheimer's andthe aging brain. Don't you guys go
anywhere all man. But that doesn'tbother me, not because I am happy
and freely adm I'm inappropriate for myage. You may think that I'm all
(19:51):
love. It don't bother me,not even because I am happy and admin.
And hello, Hello, Hello,This is Adrian Bergen. This is
Generation Bowl, the Fountain of Truth, the fountain of truth about aging,
(20:11):
and we are going to be talkingabout Alzheimer's. I probably would say that
if somebody made a list of thethings they don't like about aging, that's
the number one on the list,the possibility of having dementia Alzheimer's. I
just read a wonderful sequel to abook that has been actually they made into
(20:33):
a Netflix series and so on,and it's called Olive Again. And in
the end of this journey in thisfictional book of growing older. The woman
goes into an assistant living community andthey all call Alzheimer's the dopey dope,
and they say, am I goingdopey dope? Well, it's become it.
It's become a national fear, perhapsan international fear. So today we
(20:57):
are speaking with someone who can dosomething about it, and who is every
day of his life doing something aboutit, doctor Martin Toler, And he
is the founder, the president andCEO of al Zion, already in the
midst of a phase three with regardto the possibility of getting to the market
(21:18):
and through the FDA an oral medicationthat will maintain delay and hopefully one day
be used for prevention of Alzheimer's.Now, I promised you a personal story,
and I'm going to ask doctor Tolerto respond to it. But before
I do, I'm going to askhim a general one. So it is
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said, how many people, andyou already gave a huge astronomical number,
who'll give it to us again,we'll get Alzheimer's that it's almost inevitable with
regard to aging. Does that showup? Do you believe that there's an
inevitability if we live long enough oris there something else? Is there?
(22:02):
Because I know that you're involved ingenomes, is there a genetic connection here?
We do find that people in thesame families have Alzheimer's. What is
the marker? Will say, Iwon't just a biomarker for us to consider
whether we should be looking into thepossibility of Alzheimer's in our futures. So
(22:26):
the tragedy of Alzheimer's is that it'sinevitable as a strong word, but it's
really driven by aging. And ifyou look at what we call the capital
and bias or Barborker then meets followingpatients with different genotypes, you know,
long enough everybody at the end,you know, kind of gets to the
disease, even though it may happenin the later age, and just to
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bring it home. So in theeighties, every third patient, thirty percent
of the patients will have clinical stage, determinal stage of Alzheimer's disease. Right,
So this is how you know,profound the impact is and that's why
there has been called the plaque ofthe twenty first century. You know,
really the biggest you know, notonly medical but also you know a challenge
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for humanity as we are as wehave right now. So the and the
reason for that is that our brainis incredibly metabolically active. We burned about
twenty percent of the energy in thebrain and it's only two percent of the
body and has enormous amount of byproducts. It's actually weight of the brain.
So we generate about three pounds ofthe byproducts of the junk of the toxins
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every year, and we need toclear it out as we get order.
Our vessels are not able to dothat, and some of the proteins get
stuck and they cause additional disorders Alzheimer'sdisease, parkins disease, ALS, and
so forth. So it's all causedby these proteins that then misfold called what's
called prehounds, and then start aggregatingand causing the toxicity. So the genetics
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may accelerate the disease, and there'sa gene called april eye proprotein E four
that has been very strongly associated andthat can accelerate the disease quite up to
a decade. But again, unfortunately, the age is by far the strongest
driver. And while there are patientshunt they old that don't have much of
a damage, you know they areon the paths and again all of us,
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at some point, you know,we'll start accumulating these toxic in the
brain. So unfortunately, you know, that's the that's the reason why it's
becoming such a huge problem for society. Well, you know, I'm going
to tell you this story because I'mon your side. Now I want you
to get you on my side.Somebody hit me in the head with a
(24:40):
backpack. Now that's the funny part. How do you like that? Do
you hear the rest of the storyThat was on an airplane? You know
how they do those moves the backpack. They don't look to see that there's
a short person behind them, andit was extremely difficult. I was in
Europe for quite a while and Icame back and I was feeling a lot
of pain, and they gave mean MRI because they really wanted to see
(25:00):
was was their brain damage and alsowas there a tumor. They didn't know
what it was turned out to be. Nothing. Turned out to be that
the guy gave me a stiff neckand I had to do a little physical
therapy and I'm great, but wedidn't know. So the report comes back
and here's what it says, first, I was very insulted. It says,
this woman has an unremarkable brain.That's actually what it said. And
(25:26):
then it says, you can hearfrom the from I know you want to
hear. That was the good nose. That was the good nose, that
I had an unremarkable brain. Andthen it said, but very slight atrophy.
No follow up necessary. So Iwent bananas and I went to my
doctor and I said, what doyou mean atrophy? Says, oh,
(25:48):
oh no, that's that's normal inan aging brain. You might have had
that all the time. You justnever had an MRI. I didn't know.
I really take, um, what'sthat why? Because there's an expectation
culturally that our brains will atrophy.Now it happens to be biologically possibly correct.
(26:08):
But as long as there's the expectationthat we will cognitively decline, it's
not going to be such a bigdeal to the medical profession or those that
fund medicine. And here's my bottomline, subbus point. We have limited
resources for children's health, for dentistry, for hearing, for site and once
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we feel that it's normalizing a decline, we don't have to fund fixing that
decline. Now Alzheimer's happens to besuch a terrible problem because it is costing
us a tremendous amount of money inhealth care and long term care and so
and so money is pouring in toAlzheimer's. But once that breakthrough has been
(26:59):
taking care for those with problems whoalready have the disease, I'm not so
sure that all that money is goingto go into the prevention of Alzheimer's for
people who might be you know,have a precondition because of this cultural issue
that you're supposed to decline as youage. It's okay, there's no problem
in it. In fact, yourbrain is unremarkable, even if it's a
(27:22):
little atrophied. I don't like that, and I'm just wondering if it impacts
you that the entire culture around aging. So a few few points. So
number one, again, it usedto be cultural and medical profession has been
accepted that you kind of start becoming, you know, as you age,
(27:44):
you know, forgetful and sort oflose these abilities. It's very it's changing
very rapidly, and we now treataging as a disease because again, we
know why people age, and it'snot just the brain aging. It's not
just the Alzheimer's, but we knowwhy people ah, we know the mechanisms,
and there are more and more approachesto treat aging literally the aging process.
(28:07):
So you know, the regulators stilldon't like it, but again there
are a lot of approaches therapeutic andso forth, lifestyle that can slow aging
right or or hopefully it's at onepoint prevent. So this this is the
first point, and you were absolutelyright, right it was considered to be
normal to start losing some abilities,but it's not anymore. And people very
(28:30):
you know, emphatically kind of sayno, this is actually a pathological process
that can be stuck. And I'llactually one other thing, which to me
was a major concept that you know, the health. If you go through
medical school and kind of medical training, health is all considered not having a
disease. It's actually what you reallythe way you should think about health is
about function. It's all health health. Health is about what you can actually
(28:53):
do. It's all about you know, the functioning, how functional you know,
what you can do, what wereyou able to and so forth.
So so if you look at itthat way, then you look at aging
and kind of approach to uh,to to human health and you know,
and very differently the way it appliesto the to the brain. You know,
the Alzheimer's disease has been such atremendous problem again not on the not
(29:18):
just on the personal level, becauseit truly erupts you of your identity,
right that that's the that's the tragedyof Alzheimer's, that kind of the very
you know, uh, your veryidentity and kind of personality and is damage.
Uh And and the first you know, patient of doctor Alzheimer's said,
uh, you know quote you know, she was fifty year fifty year old
(29:41):
lady said, I have lost myself, right you really that's the kind of
personal strategy tragedy. But on theeconomic it's been such a huge, you
know cost in the US right nowit's about a half a trillion dollars.
It's kind of rise to trillion inthe next decade or so. So that
is the other part of and that'swhy people so much focus on it.
(30:02):
But you're absolutely right, the fundamentalchange in the approach to aging is that
it's not normal. That's not andthere are some people that can avoid it,
and there are there are a numberof approaches that can now be explored
and taken both for the brain agingbut for the overall aging as well.
Yes, and I'm going to beat the Geneological Society of America. I
(30:22):
told you about that off the air, but I'm telling everybody that would be
in March, I'm keynoting. Andwhat I am going to be doing is
talking too to gerontologists about geoscience breakthroughs, specifically so that they see aging in
a different way. You have tounderstand that a gerontologist will see the worst
(30:42):
of aging. Their work will beto make it better to age badly so
that people are more comfortable in They'regetting music, they have Alzheimer's, and
they're getting the highest level of thrivingthat you can in decline. And I
want to change their thinking that TOLLAto thinking that that's where the rabbit was,
(31:02):
not where the rabbit will be.The rabbit will be healthy aging throughout
the life course. Now, whenwe come back our last segment, I
want to talk a little bit aboutthe money, uh and UH what it
might cost and will there be Al'swhat I call Alzheimer's equity. Will everybody
be able to get some of thesebreakthroughs that you are creating for us in
(31:25):
our world, don't you guys,go anywhere. But that doesn't bother me,
not even because I am happy andI'm inappropriate for my aged You may
think that I'm all. That doesn'tbother me, not even because I am
(31:51):
happy and I'm inappropriate. Oh my, and hello, Hello, Hello,
This is Adrian Bergen. This isGeneration about the Fountain of Truth, the
fountain of truth about aging, andwe're here today with doctor Martin Toler.
He is the founder, president andCEO of al Zeon, and we've been
(32:14):
talking about Alzheimer's, but now I'mtalking about something a little different, and
that is financing the breakthroughs that arecoming very quickly by the way at us
to intervening in aging, maintaining ourfunctionality, as Martin would say, as
he just said, functionality is justas important as a component of wellness as
(32:40):
his disease, but also giving uswhat I call longevity equity. Everybody knows
about health equity. We should allbe able to get a doctor in affordable
this if we're sick. But whatabout maintaining our health span. That's a
different problem, because there's no reallyI've an insurance for these kinds of things
(33:01):
to reimburse you. So here wemay have an FDA approving a medication for
people who have Alzheimer's, but mayor may not approve a medication to prevent
Alzheimer's. There's plenty of things likemetforman that may and maybe rap myysin.
We talk about it that a loton this show. That might even prevent
(33:23):
or reverse aging reverse, but whocould afford it? So let me throw
that back to you, Martin.What's your take on this? I mean,
you're going through the FDA hoop sothat people could get this pill covered.
Otherwise it's it's almost valueless to themillions you're talking about. But do
you think we'll ever get to thestage where we do not have to call
(33:45):
aging a disease in order for theFDA to approve covered medical breakthroughs and devices.
So let me kind of take asemi steps. So, the first
step in bringing the treatment to patientsis to get a crew from the regulators,
(34:07):
that's the FDA in the US,EMA in Europe and so forth,
and they for Alzheimer's disease. Theyunderstand that we initially start again and the
patients in the terminal stage, inthe chronical stage, and then then we
move to the you know, presymptomaticand so forth, and there's a path
(34:28):
for that, and they really theirjob is to say, the data that
you gave me, you know,I fully understand it. You covered kind
of all the bases, and Ican describe what this drug does, so
you can get what's called the label. The second part, which is completely
separate from especially in the US fromthe regulators not so much in Europe,
is the cost and who is itgoing to pay for it and how's it
(34:50):
going to get reimbursed? And that'scalled the payers. So there are a
number of groups that you know,really you know, pay for the cost
of the medication or manage the medicalcare. And they are very interesting in
in treatment for Alzheimer's disease because thecost is enormous and they realize how you
know, impactful of this would beto all, you know, kind of
(35:14):
taking care of the of the patientsthey are responsible for. So and we
have been in fact approached by thepayers because they realize that, you know,
simple pill could be much more costeffective than than the than the infusible
antibodies which require you know, monitoringfor brain brain breeds and so forth.
So so at this stage, youknow, we really our concern is not
(35:37):
with getting through reimbursement for our treatmentfor either the clinical station of the treatment
when the patients have the symptoms,and and potentially even in the preventative because
there are there's a whole scale youknow, of the kind of the prevention
in the what we call them modcognitive impairment, which is right before be
(35:58):
able to full clinical symptomatology. Andso for it now what you're talking about,
you know wrote the question. Soagain, we don't really worry about
having their eimbursement for our treatment forthe patients that would need it. Now,
the treatments for aging, it's adifferent problem, right, not a
diagnosis. It's that a disease,I hope exactly so, so because you
(36:20):
truly won't have to say and thereare some approaches now that trying to test
it is. The Tame study wasthe mid format and what have you,
where you really say, you know, I'm enrolling the healthy people. I've
got to follow them for a decadeand then I want to see whether the
major morbidities and mortalities have been decreased. Right, So that's really the goal
for the TAME study that their Bargeliis doing um at al Brandstein. So
(36:45):
so that is the ones that theagency has not done yet, you know,
saying, Look, I mean,there are these these processes in the
body that really are driving the aging. That's why we should consider a disease,
and that's why we should be ableto approve and ultimately reimburse you know,
the treatments that actually can act againstthese processes. Let me give you
(37:07):
my point here, and you're givingan example that's perfect. So met Foreman
is given to people with diabetes,right, And my husband takes it because
he's been diagnosed diabetic and it's avery effective drug. And I don't it's
been around sixty years. I seeno side effects, etc. Etc.
But everyone I know, everyone whois a gerroscientist that I've spoken to,
(37:31):
takes metformant but they are not diabetic. They get it, and many doctors
I know, and they pay forit. They pay for it out of
their own pocket the way you guysmight pay for a neutraceutical, or you
might pay for an expensive vitamin,fancy vitamins, and they take it.
This is what I mean, doctortoler about longevity equity. If it's true
(37:54):
that met Foreman can reverse certain symptomsor prevent certain symptoms of aging and let
us function better, some people canafford it and other people will not be
able to do that unless our regulatorsmake a change of their thinking. And
(38:14):
with Alzheimer's, as you said,it's so expensive that they have to.
It's so expensive to the country.We spend more money on healthcare, but
the number one expenditure per person inthe world, and we're only number sixty
three in the healthy aging among firstworld countries because our money is going to
Alzheimer's and not anything else. Maybeyou'll you're the one who's going to make
(38:37):
that change, But I don't getit. This is just a real name
is I don't get it. Whywould they not have a different standard of
coverage for medications. It's going totake ten years before this Tame study is
over, and yet there are peopleof meetings already taking mid Foreman right this
(39:00):
minute. So this is what Imean by health equity. And since you've
been thinking about it in addition toAlzheimer's, where do you see that going?
Do you think it's going to befor the people of means only to
get these preventions, or there'll bea regulator change of heart. That would
be the regulator change of heart.What you need is a clear proof that
(39:22):
the approach is like the Tame studywas meant forming on some other intervention really
change the course of aging, becauseI think the mindset it's always still you
know, in it starts with inthe minds of the scientists and clinicians,
and then the regulators follow. There'sno you know, you know, I
guess they should, but there's reallynot much happening because that would be kind
(39:44):
of proactive, so they are reactive. But again, I mean, once
you have a clear proof that somethingworks, you know they will come along.
And you know, it's not sodissimilar what happened in Alzheimer's just in
over the past year, because againit was you know, it was considered
impossible, unsolvable. But now thatwe have a positive data, you know,
from our program and from the otherprograms, it's it's it's clear to
(40:05):
the regulators that this is this nowhas as a path that they need to
support. They were willing to dothe the what's called the accelerated approvals.
They were willing to give all thedesignations that kind of accelerate the access to
the medications and so forth. Soit's clearly, you know, reactive,
but it's I'm sure that the regulatorswill be there, and I believe that
(40:28):
the pairs will be there, right, So you have to realize that the
approval of the medication is just onestep and real control or what gets used
and how widely have the pairs thoseare the ones that really say I'm going
to pay for it for these patientsor not. So let's be very helpful
and say it's just all a matterof time. So we want to keep
(40:50):
ourselves as healthy as possible waiting waitingfor this, So let's talk about that
for a minute. Because you're soimmersed in pharmaceutical doesn't mean that you are
not also immersed in exercise nutrition asthey say, nutriuticals, that we can
do things we can do right nowto prevent or maintain where we are with
(41:15):
our aging. I've always asked thisquestion. Some of them geroicize as chicken
soup, But you tell me what'syour personal take on that? Yeah,
yeah, so, Drian, Soit's striking how the non medical approaches are
impactful. Right, So, asI said earlier, you know, when
you go through medical school, youthought that you know, the definition of
(41:38):
health is the lack of disease.That's too late, right. The definition
of health really should be the function, what you can do, what you
actually the task and things you cando and how well you can do them.
And you know, vast majority ofthe interventions are non medical. Are
exactly what you say, nutrition.The lifestyle is able lifestyle intervention. We
(42:00):
understand better and better that you know, really most of the impact of you
kind of have, especially in thekind of the when you're young and healthier,
you know, you know, noteven so yag in the fifties or
sixties are going to be lifestyle nottherapeutic. Right. There are some drugs
that clearly you know, started topop up as potentially you know, a
(42:21):
slow ink or prevent the aaging.But again, the major impact of it,
you know, vast majority of interventionour lifestyle. And that's where everybody
has enough ability to do that.You know, when we did a big
conference, the Catalis Institute conference,we had geroscientists and I absolutely insisted and
(42:42):
we did have panels on behavioral health. Why because we know what to do,
we know how to eat right.Intermittent fasting. We talk about this
all the time. This is notfor biohackers. You ask somebody playing pickaball,
they'll they'll tell you about intermittent fasting. We know about coqu ten,
but do we do it. No. We still know that forty six hours
(43:06):
a week watching TV is the averageamount of time that retires it and watch
television it's more than a work week. So that's a big deal. We
have to hear. You have tosay this thing loud and proud that it
works. So I want to hearit again. It works. It's worth
it to do this, and it'sthe biggest impact. You know, there's
(43:30):
nothing anywhere closed to impact on healthand longevity as you have from exercise.
Right number one is exercise diet.Obviously we all know what's healthy, what's
not, you know, the wholefoods. And the last thing is the
fastening. Right again, the Ialways go back to Platon said, you
know, I'm fastening for the clarityof my mind. The fasting is the
(43:52):
best thing anybody can do for theirbody and for their brain. It should
be regular part of the This isthe reason why all the you know religions
have actually fasting. It's not foryou know, any religious reasons. It's
really most of the religions. Youknow, the prescriptions are health prescriptions.
The fast thing has been around forthousands of years. And again, Platinum
(44:13):
two thousand years ago knew how criticalthe fasting is. The best thing he
can do for you. Just don'teat for a few days. Now,
you're very busy, and you believein this, and you do it.
Do you have any hints and tipsabout how you discipline your own self to
do this? You know, Iwhat I do. And again it's a
system that again I have been developingfor you know, since since I was
(44:36):
you know, in the teens.It's really it's almost like Olympics for your
brain. Right. Again, Ineed to be very active and on the
top. And these are the thingsthat keep me active. You know,
I fast on the weekends. Youknow, I run. You know again,
I'm going to be running in justa few minutes when we're done with
this discussion. You know, youreally need to the very basics are the
drivers of your ability to function.Right, and again, it's the when
(45:00):
you eat, you know, howyou move, how you sleep, sleep
is you know, the best corlettewith Alzheimer's diseases actually how how well you
sleep, because you clear the toxinsfrom the brain when you sleep, only
when you sleep. So the verybasic things you can do in the lifestyle
are the most impactful. Once everythingfails, you may go to some therapeutics
(45:22):
or some drugs, but you reallyit's the it's the very last resort.
It should not be because again yourability to you know, function and age,
well, if you call it thatway, you see in your hands,
and it's all about the lifestyle,almost all about the lifestyle. Well,
this is a wonderful, inspiring wayto finish a show. I couldn't
thank you more. And from goingto the scourge of Alzheimer's to what we
(45:45):
can do for ourselves was a beautifuljourney. Thank you so much for being
on the show. Thanks so much, Adrian. And you know what I'm
going to say to you guys,get out their kids and make it happening appropriate
When I look in the mirror,I don't see wrinkles. When I look
in the mirror, I see hairon my head, not my shoulder.
Hello. Hello, Hello, Thisis Adrian Bergen. This is Generation Bowl,
the fountain of truth, the fountainof truth about what well, the
(00:31):
fountain of truth about aging. Andwe're going to get right to it right
now because we have a very specialguest and he's not been a guest for
the first time today. We arereally following in his footsteps over the past
year or more when he was onand as I said to him off the
air, you've been busy. Andwho is he. He's Martin Toler,
Doctor Martin Toler. He's the founder, he's the president, he's the CEO
(00:55):
of al Zeon, and he ishere with a gift, a gift for
all of us of peace of mind, the potential, the potential that in
the future Alzheimer's will not be aword that Zack kids will know. We
know it, and it is abarrier, I can tell you. It
stands in the way of all ofour peace of mind with regard to aging.
(01:19):
Many people feel that they are moreafraid of living with Alzheimer's than passing
away. As a lawyer in thefield, I can tell you that these
ideas are very popular today. Peopleare making special powers of attorney so that
they don't have to live through anAlzheimer's lifestyle. This is a terrible,
(01:45):
terrible scourge, also very expensive.So when I say that doctor Toller is
a hero, he's going through thehero's journey and he has made some wonderful
progress you want to hear about,Martin. Thank you so much for being
with us today. Thanks so much, Adres and for such kind words.
Well, it is true on theradio, you know. I know that
(02:07):
Joe's scientists, people like you,people who are in the field, they
go through this day to day.They don't even have time to pick up
their head to see what they're doingand where they are in life half the
time. So I think it's it'sonly right to say things like this,
Now, what are you doing?Tell us about the little, a little
and the big aspects of your newbreakthrough. So the breakthrough it's not only
(02:31):
at Alzayon, but also at thewhole field of Alzheimer's. The so just
kind of a little bit of history. So this is our fourth company.
Was this team we have been onthis for a couple of decades. Founded
Alsayon about ten years ago now almostten years ago, and the our goal
(02:53):
at Alsayon has been first to solvethe scientific puzzle, meaning what is causing
the dizzy and that has been themajor barrier for success in treating the disease.
And we really uncover the puzzle.We were able to solve you know,
what is the toxic agent, howto go about it, and so
forth. And now our data butalso data from the other programs UM that
(03:16):
we're going to talk about, haveconfirmed that this is this is really the
solution and this is the approach thatcan help patients, which really has been
the major, major, major breakthrough. So we we know that at least
one path to alleviating the disease andpotentially also preventing it, as you mentioned
earlier, has has been has beenyou know solved. UM. Now the
(03:40):
our breakthrough has been so we reporteddata from our face to study Face to
be studied which showed very profound effectof our drug on both the buy markers
of the Alzheimer's disease some of thethe ways we can assess the brain damage.
Again, there was superior to theother approaches with the antibodies. We
(04:04):
also show that we can slow brainatrophy in particular the hippocampal atrophy again uh
superior to the to the effect ofthe antibodies. And finally, we have
shown that we can stabilize the cognitionin the patients who are in the terminal
stage of the disease, meaning thechlinical stage of the disease. So that
has been m kind of on ourend. We reported both six and twelve
(04:27):
months data from that study. Wealso completed enrollment in our Faith three,
so we will have the data thatwe believe will help us register the treatment
so it can get to the patientsin the middle of next year. And
finally, the breakthroughs in the inthe broder Alzheimer's field has been There were
two drugs that have been approved bythe FDA UM and only the most recent
(04:54):
one drug called thecanomat from EASTI,showed very convincing again that the approach to
targeting what we call the toxic solubleaneloid. Again the science that Alsion Bill
and written the papers about and hasbeen all confirmed. So we want you
to know as you're listening why doctorTeller is on top of the entire field
(05:15):
because he serves on business and scientificboards that deal with Alzheimer's neuroscience. He's
been a professor at the Yale UniversitySchool of Medicine. I don't have to
give you all these credentials because it'sa short show, but one of those
boards is the Drug Discovery Foundation andthe Alzheimer's Foundation and Advanced Healthcare Management Institute.
(05:35):
So with all of this background,I do know that on an emotional
level, your real target is prevention. And you have said that the new
growth in biomarkers, being under ableto understand parts of our own body and
have their functioning goes hand in hand. We usually look at doctor Teller at
(05:57):
biomarkers from a biohacker point of view, Did I gain weight? You know
what's my blood pressure? Ha's myheart rate? And then more sophisticated looking
at you know what's my cell healthof mito country. We talk about this
on the show all the time,but you're looking at it in a little
bit different way, and that ispart of preventive health, particularly with regard
(06:20):
to Alzheimer's. Can you tell usa little bit about that now, So
I'll start with the course of theAlzheimer's disease. So it's very important to
understand that what we call Alzheimer's isthe terminal stage, the clinical stage where
patients have clinical symptoms, they starthaving memory problems, and that it progresses
(06:42):
in few years to death of thesepatients. That's really the very final again,
the terminal stage. The real majorityof the disease is the first twenty
or twenty five years of the diseasewhere there's accumulating injury of the brain.
And this starts in the fifties,you know, even in the forties,
depending on how what's your genetic backgroundand so forth, And this is the
(07:05):
time where we can intervene, andwe should intervene, and and our treatment
that it's oral, that has afavorable safety and that can be administered for
literally for the rest of the lifeor for decades, UH is suitable for
this. And that's ultimately, asyou said, Ran, that's that's our
(07:26):
goal, m because again you youwe have an opportunity with understanding the biology
and the science behind the Alzheimer's disease, number one, using the biomarkers to
find the patients, and number twoto treat them. Before they have the
chinical symptoms. Now, the diagnosishas been absolutely essential for our success and
success of the other companies because nowwe know how to find the patients not
(07:49):
only very you know, with ahigh degree of accuracy when they have the
symptoms, but also before they havethe symptoms. That's called the biog from
definition of Alzheimer's and what it alsoshowed, and there have been a number
of papers now published that you know, we thought the number of people used
it was forty fifty million people onthe planet that they have the disease.
(08:11):
If you look at it from thebiological definition, it's over four hundred million.
People's actually fine a million. Sothat's the that's the number of patients
that really need this treatment. Andagain that could be held primarily in the
preventative it was the preventative fashion.Well, we come back. We're going
to pull a little bit of adifferent side of doctor Martin Toler, and
(08:33):
that is his business side. We'regoing to talk about getting to market because
that's really ultimately what we care about. We want that the pill, we
want to be able to understand it, and we want it to be safe
for us. So we will betalking about that in the context of his
Phase three trial. And then I'mgoing to tell you a story, and
that story is, well, I'mgoing to tell it to you in a
(08:56):
funny way, but it wasn't sofunny for me. Don't you guys,
go anywhere. We will be rightback. But that doesn't bother me,
not because I am happy and I'minappropriate for my aged da You may think
(09:18):
that I'm all doesn't bother me,not even because I am happy and I'm
inappropriate. Oh my, and hello, hello, Hello, once again,
This is Adrian Bergen. This isGeneration Bold, the Fountain of Truth.
(09:39):
I know that you're riveted to thisbecause I know that Alzheimer's is really the
thing that all surveys, all gerontologicalsurveys, gerontology surveys show is the most
fearful thing, even greater than theend of life for the older adult.
(10:00):
But we've just heard from doctor MartinToller, who is the founder, the
president and the CEO of Alcon,that it's not only the older adult,
that this is something that can bedetected, diagnosed lingers and begins in the
body in the forties, maybe evenyounger, certainly in the fifties and therefore
the research go toward prevention. Nowbefore we go and talk about how this
(10:24):
is going to happen, because we'rereally talking about delivering your future to you
when we deal with this question.I do have one important announcement that is
thrilling to me. I've been namedthe United Nations representative from the International Federation
of Aging. The International Federation ofAging IFA is something you could look at
(10:46):
online at IFA dot org. Youwill see that it is a conglomeration of
everybody who's fighting on every platform forbetter aging worldwide. And I'm thrilled to
be able to do this podcast inthe summer from Bangkok from the floor of
their major convention and conference. Andi have a new podcast which is launching
(11:11):
tomorrow. It's called On the Ground. I'm now the podcaster for the United
Nations Global Communications Committee. And whatare we communicating. We're communicating what's working
in the world of civil society andin the world of nonprofits. So we're
sick and tired of complaining that wecan't get anything done, that the world
(11:33):
is going to hell in a handbasket, and instead we're telling you what is
working in a way that you cantake it and make it your own in
your organizations wherever you may be volunteeringor even in your corporation. We will
provide you what I call a heatmap to look around your own organization and
(11:54):
see what's working and concentrate on thatinstead of always focusing on what's not okay.
So exciting times for change, andof course when we speak to doctor
Tyler, we're talking about change Phasethree. Phase three is something that is
the beginning of getting these breakthroughs tous. Explain that process to us and
(12:18):
what's happening with regard to your particularphase three trials. So phase three is
the last stage of drug development.The process usually takes, you know,
from the initial idea to completion andthe average fourteen years, but this is
the last you knows a few yearswhen you when you really have to confirm
(12:41):
in the large group of patients thatthe dark works and get all the attributes.
Then you can then bring to theregulators and ask them for approval,
because the approval really means that theyhave to you have to find you know,
uh, you have to really bringthe information regarding the safety, the
efficacy and performance of these treatments andreally have sufficient number of patients that show
(13:07):
that you're confident in the in thein these data. So that's the phase
three. We have completed the enrollmentin our phase three, and that means
that we're just following the patients inthe trial and we will have the data
in the middle of next year,and we're hoping to ask for the what's
called new dark application, the approvalthe FAM later next year. Well,
(13:31):
congratulations and of course godspeed on thatone. But I'm worried about two things.
Let's start with number one. TheFDA is not known for proving preventions
now to the extent that there's amaintenance of cognition. In other words,
things won't get worse with somebody whoalready has in Alzheimer's diagnosis. What you're
(13:56):
doing is perhaps a shoe in withregard to the FDA, because some people
call the NIA the National Institute onAging the National Institute on Alzheimer's, because
it gives ninety percent of its moneyit spends it because Alzheimer's is such a
scourge. But you and I arevery focused on prevention, and you just
(14:18):
laid out to us beautifully the possibilityof using early diagnostics and not an offering
medication offering treatment to people before anofficial diagnosis of Alzheimer's, which is what
we all really want. What doyou think of the FDA's position there,
and can you show the same thingthrough a phase three trial for both applications
(14:43):
of this breakthrough. So we're ourcurrent phase three trial is in patient in
the terminal station. It means theclinical station in the early early clinical stage.
And the reason is that to seekapproval, we was the current standards
and the current evaluation and the scaleswe need to do the evaluation in the
(15:07):
patients who are to have the disease. And so these you know, scales
have been already approved and accepted bythe FDA. Now, the biomarkers that
you highlighted are going to be incrediblyuseful and important, and the data that
we already have for running a trialin the prevention, so that then you
will find the patients based on theirplasma biomarkers. Now we can do these
(15:31):
diagnoses from plasma and and and Ireally follow them. And once you know
you make the connection between the biomarkersand the clinical performance, you can say,
you know, I have stopped thisevidence of the brain destruction which is
the petile for instance, that wehave seen very robust effect on. And
then you know, as for approvalfor the prevention. So the first step
(15:52):
always is that you need to goto the disease population um. But again
everybody understands, really the majority ofthe patients, really eighty ninety percent of
the patients are in that what doyou call the pre symptomatic stage, because
again, the way the disease evolvesis that there are you know, destruction
(16:12):
of the brain, tissue, ofthe neurons, the brain cells, and
at the point where the brain cannotcompensate because the brain has a high ability
to compensate by what's called the plasticity. That means the other parts of the
brain can take over the function ofthe destroyed parts of the brain. But
at some point the whole system collapses, and that's when you know you have
(16:34):
the chronical symptoms. So we wantto go to that stage, you know,
way before that decase, before that. Yeah, to use a metaphor
that I've heard, if you havea four legged stool and one leg is
not doing very well, but it'sa fairly new stool, people haven't set
on it much. I won't falldown by the time, lots of people
(16:55):
have said, on that stool,the other three legs can't compensate for the
weak one, and so the wholestool falls apart. But at the beginning,
you didn't know that, you didn'teven know you had a weak one
leg there because it was functioning.It was working. So if I can
use that homade metaphor, you canunderstand what we mean here by prevention.
(17:15):
It's not that you're taking somebody withno symptoms and you're giving them a pill,
like we might all be taking avitamin even though we may not need
it. We think, well,can't hurt. It's not that kind of
thing. So this is something wherethey're going to have to be able to
show that they have clear clinical proofthat this diagnostic creates a pre Alzheimer's condition,
(17:37):
like we have heard pre diabetes.The only drug that's really so far
been FDA approved for people who letus call them totally healthy, are statins.
I never understood how that got through. I'm only happy they do.
But it is for prevention, purelyprevention for hard issues, even for people
that don't even have hard issues.But this is a different poll game,
(18:00):
and I'm a little briskly about that, doctor Teller. I don't know why
we have to run through so muchhoops for prevention, but as you just
outlined, as we do, Iwant to tell you my second concern.
I promise everybody I would tell alittle story, and I'm going to hold
it off for our next segment.But I'm gonna end this one by asking
you how long is Phase three?When do you think you'll be completed with
(18:25):
this and making your applications? Sothe Phase three takes or our Phase three
US projected for about three years duration, but we have completed the first part
of it, which means finding theright patients, which is always the most
challenging, and now we just completingthe follow up, which is a year
(18:45):
and a half in those patients thathave been already enrolled. So we completed
the enrollment last year, which hasbeen big success because it's been in the
midst of the pandemic and it's beena huge excitement around the program, again
probably given by the fact that howwell differentiated our treatment is um so were
having enrolled to study, you know, ahead of timelines, and even it's
(19:06):
a larger number of subjects. Butnow we're waiting again to follow up which
the year and a half. Soby middle of next year we will have
the data the readoubt. Okay,so now I'm going to take a little
bit of a break. We'll comeright back. And I want to pose
through a story, a personal storyof mine, an agist aspect of how
(19:26):
the medical profession looks at Alzheimer's andthe aging brain. Don't you guys go
anywhere all man. But that doesn'tbother me, not because I am happy
and freely adm I'm inappropriate for myage. You may think that I'm all
(19:51):
love. It don't bother me,not even because I am happy and admin.
And hello, Hello, Hello,This is Adrian Bergen. This is
Generation Bowl, the Fountain of Truth, the fountain of truth about aging,
(20:11):
and we are going to be talkingabout Alzheimer's. I probably would say that
if somebody made a list of thethings they don't like about aging, that's
the number one on the list,the possibility of having dementia Alzheimer's. I
just read a wonderful sequel to abook that has been actually they made into
(20:33):
a Netflix series and so on,and it's called Olive Again. And in
the end of this journey in thisfictional book of growing older. The woman
goes into an assistant living community andthey all call Alzheimer's the dopey dope,
and they say, am I goingdopey dope? Well, it's become it.
It's become a national fear, perhapsan international fear. So today we
(20:57):
are speaking with someone who can dosomething about it, and who is every
day of his life doing something aboutit, doctor Martin Toler, And he
is the founder, the president andCEO of al Zion, already in the
midst of a phase three with regardto the possibility of getting to the market
(21:18):
and through the FDA an oral medicationthat will maintain delay and hopefully one day
be used for prevention of Alzheimer's.Now, I promised you a personal story,
and I'm going to ask doctor Tolerto respond to it. But before
I do, I'm going to askhim a general one. So it is
(21:40):
said, how many people, andyou already gave a huge astronomical number,
who'll give it to us again,we'll get Alzheimer's that it's almost inevitable with
regard to aging. Does that showup? Do you believe that there's an
inevitability if we live long enough oris there something else? Is there?
(22:02):
Because I know that you're involved ingenomes, is there a genetic connection here?
We do find that people in thesame families have Alzheimer's. What is
the marker? Will say, Iwon't just a biomarker for us to consider
whether we should be looking into thepossibility of Alzheimer's in our futures. So
(22:26):
the tragedy of Alzheimer's is that it'sinevitable as a strong word, but it's
really driven by aging. And ifyou look at what we call the capital
and bias or Barborker then meets followingpatients with different genotypes, you know,
long enough everybody at the end,you know, kind of gets to the
disease, even though it may happenin the later age, and just to
(22:48):
bring it home. So in theeighties, every third patient, thirty percent
of the patients will have clinical stage, determinal stage of Alzheimer's disease. Right,
So this is how you know,profound the impact is and that's why
there has been called the plaque ofthe twenty first century. You know,
really the biggest you know, notonly medical but also you know a challenge
(23:10):
for humanity as we are as wehave right now. So the and the
reason for that is that our brainis incredibly metabolically active. We burned about
twenty percent of the energy in thebrain and it's only two percent of the
body and has enormous amount of byproducts. It's actually weight of the brain.
So we generate about three pounds ofthe byproducts of the junk of the toxins
(23:34):
every year, and we need toclear it out as we get order.
Our vessels are not able to dothat, and some of the proteins get
stuck and they cause additional disorders Alzheimer'sdisease, parkins disease, ALS, and
so forth. So it's all causedby these proteins that then misfold called what's
called prehounds, and then start aggregatingand causing the toxicity. So the genetics
(23:56):
may accelerate the disease, and there'sa gene called april eye proprotein E four
that has been very strongly associated andthat can accelerate the disease quite up to
a decade. But again, unfortunately, the age is by far the strongest
driver. And while there are patientshunt they old that don't have much of
a damage, you know they areon the paths and again all of us,
(24:19):
at some point, you know,we'll start accumulating these toxic in the
brain. So unfortunately, you know, that's the that's the reason why it's
becoming such a huge problem for society. Well, you know, I'm going
to tell you this story because I'mon your side. Now I want you
to get you on my side.Somebody hit me in the head with a
(24:40):
backpack. Now that's the funny part. How do you like that? Do
you hear the rest of the storyThat was on an airplane? You know
how they do those moves the backpack. They don't look to see that there's
a short person behind them, andit was extremely difficult. I was in
Europe for quite a while and Icame back and I was feeling a lot
of pain, and they gave mean MRI because they really wanted to see
(25:00):
was was their brain damage and alsowas there a tumor. They didn't know
what it was turned out to be. Nothing. Turned out to be that
the guy gave me a stiff neckand I had to do a little physical
therapy and I'm great, but wedidn't know. So the report comes back
and here's what it says, first, I was very insulted. It says,
this woman has an unremarkable brain.That's actually what it said. And
(25:26):
then it says, you can hearfrom the from I know you want to
hear. That was the good nose. That was the good nose, that
I had an unremarkable brain. Andthen it said, but very slight atrophy.
No follow up necessary. So Iwent bananas and I went to my
doctor and I said, what doyou mean atrophy? Says, oh,
(25:48):
oh no, that's that's normal inan aging brain. You might have had
that all the time. You justnever had an MRI. I didn't know.
I really take, um, what'sthat why? Because there's an expectation
culturally that our brains will atrophy.Now it happens to be biologically possibly correct.
(26:08):
But as long as there's the expectationthat we will cognitively decline, it's
not going to be such a bigdeal to the medical profession or those that
fund medicine. And here's my bottomline, subbus point. We have limited
resources for children's health, for dentistry, for hearing, for site and once
(26:34):
we feel that it's normalizing a decline, we don't have to fund fixing that
decline. Now Alzheimer's happens to besuch a terrible problem because it is costing
us a tremendous amount of money inhealth care and long term care and so
and so money is pouring in toAlzheimer's. But once that breakthrough has been
(26:59):
taking care for those with problems whoalready have the disease, I'm not so
sure that all that money is goingto go into the prevention of Alzheimer's for
people who might be you know,have a precondition because of this cultural issue
that you're supposed to decline as youage. It's okay, there's no problem
in it. In fact, yourbrain is unremarkable, even if it's a
(27:22):
little atrophied. I don't like that, and I'm just wondering if it impacts
you that the entire culture around aging. So a few few points. So
number one, again, it usedto be cultural and medical profession has been
accepted that you kind of start becoming, you know, as you age,
(27:44):
you know, forgetful and sort oflose these abilities. It's very it's changing
very rapidly, and we now treataging as a disease because again, we
know why people age, and it'snot just the brain aging. It's not
just the Alzheimer's, but we knowwhy people ah, we know the mechanisms,
and there are more and more approachesto treat aging literally the aging process.
(28:07):
So you know, the regulators stilldon't like it, but again there
are a lot of approaches therapeutic andso forth, lifestyle that can slow aging
right or or hopefully it's at onepoint prevent. So this this is the
first point, and you were absolutelyright, right it was considered to be
normal to start losing some abilities,but it's not anymore. And people very
(28:30):
you know, emphatically kind of sayno, this is actually a pathological process
that can be stuck. And I'llactually one other thing, which to me
was a major concept that you know, the health. If you go through
medical school and kind of medical training, health is all considered not having a
disease. It's actually what you reallythe way you should think about health is
about function. It's all health health. Health is about what you can actually
(28:53):
do. It's all about you know, the functioning, how functional you know,
what you can do, what wereyou able to and so forth.
So so if you look at itthat way, then you look at aging
and kind of approach to uh,to to human health and you know,
and very differently the way it appliesto the to the brain. You know,
the Alzheimer's disease has been such atremendous problem again not on the not
(29:18):
just on the personal level, becauseit truly erupts you of your identity,
right that that's the that's the tragedyof Alzheimer's, that kind of the very
you know, uh, your veryidentity and kind of personality and is damage.
Uh And and the first you know, patient of doctor Alzheimer's said,
uh, you know quote you know, she was fifty year fifty year old
(29:41):
lady said, I have lost myself, right you really that's the kind of
personal strategy tragedy. But on theeconomic it's been such a huge, you
know cost in the US right nowit's about a half a trillion dollars.
It's kind of rise to trillion inthe next decade or so. So that
is the other part of and that'swhy people so much focus on it.
(30:02):
But you're absolutely right, the fundamentalchange in the approach to aging is that
it's not normal. That's not andthere are some people that can avoid it,
and there are there are a numberof approaches that can now be explored
and taken both for the brain agingbut for the overall aging as well.
Yes, and I'm going to beat the Geneological Society of America. I
(30:22):
told you about that off the air, but I'm telling everybody that would be
in March, I'm keynoting. Andwhat I am going to be doing is
talking too to gerontologists about geoscience breakthroughs, specifically so that they see aging in
a different way. You have tounderstand that a gerontologist will see the worst
(30:42):
of aging. Their work will beto make it better to age badly so
that people are more comfortable in They'regetting music, they have Alzheimer's, and
they're getting the highest level of thrivingthat you can in decline. And I
want to change their thinking that TOLLAto thinking that that's where the rabbit was,
(31:02):
not where the rabbit will be.The rabbit will be healthy aging throughout
the life course. Now, whenwe come back our last segment, I
want to talk a little bit aboutthe money, uh and UH what it
might cost and will there be Al'swhat I call Alzheimer's equity. Will everybody
be able to get some of thesebreakthroughs that you are creating for us in
(31:25):
our world, don't you guys,go anywhere. But that doesn't bother me,
not even because I am happy andI'm inappropriate for my aged You may
think that I'm all. That doesn'tbother me, not even because I am
(31:51):
happy and I'm inappropriate. Oh my, and hello, Hello, Hello,
This is Adrian Bergen. This isGeneration about the Fountain of Truth, the
fountain of truth about aging, andwe're here today with doctor Martin Toler.
He is the founder, president andCEO of al Zeon, and we've been
(32:14):
talking about Alzheimer's, but now I'mtalking about something a little different, and
that is financing the breakthroughs that arecoming very quickly by the way at us
to intervening in aging, maintaining ourfunctionality, as Martin would say, as
he just said, functionality is justas important as a component of wellness as
(32:40):
his disease, but also giving uswhat I call longevity equity. Everybody knows
about health equity. We should allbe able to get a doctor in affordable
this if we're sick. But whatabout maintaining our health span. That's a
different problem, because there's no reallyI've an insurance for these kinds of things
(33:01):
to reimburse you. So here wemay have an FDA approving a medication for
people who have Alzheimer's, but mayor may not approve a medication to prevent
Alzheimer's. There's plenty of things likemetforman that may and maybe rap myysin.
We talk about it that a loton this show. That might even prevent
(33:23):
or reverse aging reverse, but whocould afford it? So let me throw
that back to you, Martin.What's your take on this? I mean,
you're going through the FDA hoop sothat people could get this pill covered.
Otherwise it's it's almost valueless to themillions you're talking about. But do
you think we'll ever get to thestage where we do not have to call
(33:45):
aging a disease in order for theFDA to approve covered medical breakthroughs and devices.
So let me kind of take asemi steps. So, the first
step in bringing the treatment to patientsis to get a crew from the regulators,
(34:07):
that's the FDA in the US,EMA in Europe and so forth,
and they for Alzheimer's disease. Theyunderstand that we initially start again and the
patients in the terminal stage, inthe chronical stage, and then then we
move to the you know, presymptomaticand so forth, and there's a path
(34:28):
for that, and they really theirjob is to say, the data that
you gave me, you know,I fully understand it. You covered kind
of all the bases, and Ican describe what this drug does, so
you can get what's called the label. The second part, which is completely
separate from especially in the US fromthe regulators not so much in Europe,
is the cost and who is itgoing to pay for it and how's it
(34:50):
going to get reimbursed? And that'scalled the payers. So there are a
number of groups that you know,really you know, pay for the cost
of the medication or manage the medicalcare. And they are very interesting in
in treatment for Alzheimer's disease because thecost is enormous and they realize how you
know, impactful of this would beto all, you know, kind of
(35:14):
taking care of the of the patientsthey are responsible for. So and we
have been in fact approached by thepayers because they realize that, you know,
simple pill could be much more costeffective than than the than the infusible
antibodies which require you know, monitoringfor brain brain breeds and so forth.
So so at this stage, youknow, we really our concern is not
(35:37):
with getting through reimbursement for our treatmentfor either the clinical station of the treatment
when the patients have the symptoms,and and potentially even in the preventative because
there are there's a whole scale youknow, of the kind of the prevention
in the what we call them modcognitive impairment, which is right before be
(35:58):
able to full clinical symptomatology. Andso for it now what you're talking about,
you know wrote the question. Soagain, we don't really worry about
having their eimbursement for our treatment forthe patients that would need it. Now,
the treatments for aging, it's adifferent problem, right, not a
diagnosis. It's that a disease,I hope exactly so, so because you
(36:20):
truly won't have to say and thereare some approaches now that trying to test
it is. The Tame study wasthe mid format and what have you,
where you really say, you know, I'm enrolling the healthy people. I've
got to follow them for a decadeand then I want to see whether the
major morbidities and mortalities have been decreased. Right, So that's really the goal
for the TAME study that their Bargeliis doing um at al Brandstein. So
(36:45):
so that is the ones that theagency has not done yet, you know,
saying, Look, I mean,there are these these processes in the
body that really are driving the aging. That's why we should consider a disease,
and that's why we should be ableto approve and ultimately reimburse you know,
the treatments that actually can act againstthese processes. Let me give you
(37:07):
my point here, and you're givingan example that's perfect. So met Foreman
is given to people with diabetes,right, And my husband takes it because
he's been diagnosed diabetic and it's avery effective drug. And I don't it's
been around sixty years. I seeno side effects, etc. Etc.
But everyone I know, everyone whois a gerroscientist that I've spoken to,
(37:31):
takes metformant but they are not diabetic. They get it, and many doctors
I know, and they pay forit. They pay for it out of
their own pocket the way you guysmight pay for a neutraceutical, or you
might pay for an expensive vitamin,fancy vitamins, and they take it.
This is what I mean, doctortoler about longevity equity. If it's true
(37:54):
that met Foreman can reverse certain symptomsor prevent certain symptoms of aging and let
us function better, some people canafford it and other people will not be
able to do that unless our regulatorsmake a change of their thinking. And
(38:14):
with Alzheimer's, as you said,it's so expensive that they have to.
It's so expensive to the country.We spend more money on healthcare, but
the number one expenditure per person inthe world, and we're only number sixty
three in the healthy aging among firstworld countries because our money is going to
Alzheimer's and not anything else. Maybeyou'll you're the one who's going to make
(38:37):
that change, But I don't getit. This is just a real name
is I don't get it. Whywould they not have a different standard of
coverage for medications. It's going totake ten years before this Tame study is
over, and yet there are peopleof meetings already taking mid Foreman right this
(39:00):
minute. So this is what Imean by health equity. And since you've
been thinking about it in addition toAlzheimer's, where do you see that going?
Do you think it's going to befor the people of means only to
get these preventions, or there'll bea regulator change of heart. That would
be the regulator change of heart.What you need is a clear proof that
(39:22):
the approach is like the Tame studywas meant forming on some other intervention really
change the course of aging, becauseI think the mindset it's always still you
know, in it starts with inthe minds of the scientists and clinicians,
and then the regulators follow. There'sno you know, you know, I
guess they should, but there's reallynot much happening because that would be kind
(39:44):
of proactive, so they are reactive. But again, I mean, once
you have a clear proof that somethingworks, you know they will come along.
And you know, it's not sodissimilar what happened in Alzheimer's just in
over the past year, because againit was you know, it was considered
impossible, unsolvable. But now thatwe have a positive data, you know,
from our program and from the otherprograms, it's it's it's clear to
(40:05):
the regulators that this is this nowhas as a path that they need to
support. They were willing to dothe the what's called the accelerated approvals.
They were willing to give all thedesignations that kind of accelerate the access to
the medications and so forth. Soit's clearly, you know, reactive,
but it's I'm sure that the regulatorswill be there, and I believe that
(40:28):
the pairs will be there, right, So you have to realize that the
approval of the medication is just onestep and real control or what gets used
and how widely have the pairs thoseare the ones that really say I'm going
to pay for it for these patientsor not. So let's be very helpful
and say it's just all a matterof time. So we want to keep
(40:50):
ourselves as healthy as possible waiting waitingfor this, So let's talk about that
for a minute. Because you're soimmersed in pharmaceutical doesn't mean that you are
not also immersed in exercise nutrition asthey say, nutriuticals, that we can
do things we can do right nowto prevent or maintain where we are with
(41:15):
our aging. I've always asked thisquestion. Some of them geroicize as chicken
soup, But you tell me what'syour personal take on that? Yeah,
yeah, so, Drian, Soit's striking how the non medical approaches are
impactful. Right, So, asI said earlier, you know, when
you go through medical school, youthought that you know, the definition of
(41:38):
health is the lack of disease.That's too late, right. The definition
of health really should be the function, what you can do, what you
actually the task and things you cando and how well you can do them.
And you know, vast majority ofthe interventions are non medical. Are
exactly what you say, nutrition.The lifestyle is able lifestyle intervention. We
(42:00):
understand better and better that you know, really most of the impact of you
kind of have, especially in thekind of the when you're young and healthier,
you know, you know, noteven so yag in the fifties or
sixties are going to be lifestyle nottherapeutic. Right. There are some drugs
that clearly you know, started topop up as potentially you know, a
(42:21):
slow ink or prevent the aaging.But again, the major impact of it,
you know, vast majority of interventionour lifestyle. And that's where everybody
has enough ability to do that.You know, when we did a big
conference, the Catalis Institute conference,we had geroscientists and I absolutely insisted and
(42:42):
we did have panels on behavioral health. Why because we know what to do,
we know how to eat right.Intermittent fasting. We talk about this
all the time. This is notfor biohackers. You ask somebody playing pickaball,
they'll they'll tell you about intermittent fasting. We know about coqu ten,
but do we do it. No. We still know that forty six hours
(43:06):
a week watching TV is the averageamount of time that retires it and watch
television it's more than a work week. So that's a big deal. We
have to hear. You have tosay this thing loud and proud that it
works. So I want to hearit again. It works. It's worth
it to do this, and it'sthe biggest impact. You know, there's
(43:30):
nothing anywhere closed to impact on healthand longevity as you have from exercise.
Right number one is exercise diet.Obviously we all know what's healthy, what's
not, you know, the wholefoods. And the last thing is the
fastening. Right again, the Ialways go back to Platon said, you
know, I'm fastening for the clarityof my mind. The fasting is the
(43:52):
best thing anybody can do for theirbody and for their brain. It should
be regular part of the This isthe reason why all the you know religions
have actually fasting. It's not foryou know, any religious reasons. It's
really most of the religions. Youknow, the prescriptions are health prescriptions.
The fast thing has been around forthousands of years. And again, Platinum
(44:13):
two thousand years ago knew how criticalthe fasting is. The best thing he
can do for you. Just don'teat for a few days. Now,
you're very busy, and you believein this, and you do it.
Do you have any hints and tipsabout how you discipline your own self to
do this? You know, Iwhat I do. And again it's a
system that again I have been developingfor you know, since since I was
(44:36):
you know, in the teens.It's really it's almost like Olympics for your
brain. Right. Again, Ineed to be very active and on the
top. And these are the thingsthat keep me active. You know,
I fast on the weekends. Youknow, I run. You know again,
I'm going to be running in justa few minutes when we're done with
this discussion. You know, youreally need to the very basics are the
drivers of your ability to function.Right, and again, it's the when
(45:00):
you eat, you know, howyou move, how you sleep, sleep
is you know, the best corlettewith Alzheimer's diseases actually how how well you
sleep, because you clear the toxinsfrom the brain when you sleep, only
when you sleep. So the verybasic things you can do in the lifestyle
are the most impactful. Once everythingfails, you may go to some therapeutics
(45:22):
or some drugs, but you reallyit's the it's the very last resort.
It should not be because again yourability to you know, function and age,
well, if you call it thatway, you see in your hands,
and it's all about the lifestyle,almost all about the lifestyle. Well,
this is a wonderful, inspiring wayto finish a show. I couldn't
thank you more. And from goingto the scourge of Alzheimer's to what we
(45:45):
can do for ourselves was a beautifuljourney. Thank you so much for being
on the show. Thanks so much, Adrian. And you know what I'm
going to say to you guys,get out their kids and make it happening appropriate
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