January 21, 2025 • 35 mins
Welcome back everyone.
This week we have a guest question helper as well as Dr. Todd Levine from CND LifeSciences to share with us all information about the new syn-one skin test that can help in diagnosing LBD.
Our good friend Wendy Cogan joined us to help ask the right questions so we get a better understanding of this new test.
This is a three part recording because our interview was well over an hour and a half but we had lots of questions to ask the doctor.
Enjoy part one
Link for CNDLifeSciences is
https://cndlifesciences.com/
A shout out to all out supporters including Vickie Setterberg, Kristen Medica, Tiffany Hanna, Janice Prochaska, Kara Biller, Don Pinkos, Dee Richert, Marcia Treffman, The Geraci's and everyone else who has been with us from day one.
We are doing this for all of us and we thank you from the bottom of our hearts.
Should you wish to bless us with your support you can use links below.
Copy and paste link, if needed
https://patreon.com/lewybodyrollercoasterpodcast
the GoFundMe page at
https://gofund.me/c416ecb6
Thank you for listening each week.
Don't forget to join our Lewy Body Roller Coaster Podcast Facebook page.
If you have a topic you would like us to discuss or wish to share your thoughts on any episode, please email us at lewybodyrollercoaster@gmail.com
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:03):
Hello and welcome to our podcast about living on the
Lewy Body Roller Coaster apodcast for Lewy Body Dementia
patients and their families.
Presented by Lewy Body patientsand their families.
Speaker 2 (00:13):
You will hear firsthand the ups and downs and
twists and turns of Lewy BodyDementia From families directly
affected.
We'll share our support andexperiences on all things Lewy
Body.
Speaker 1 (00:25):
We're your hosts, Linda and Curry.
I have a loved one with LewyBody Dementia.
Speaker 2 (00:30):
And I am living with Lewy Body Dementia.
Speaker 1 (00:33):
Let's get started.
Welcome back podcast family.
Speaker 2 (00:43):
Yes, welcome back y'all.
Speaker 1 (00:45):
Just another quick shout out to everyone for your
continued support and patience.
We were good there for like twoweeks, curry, they came out on
time and then this past week,hiccup, but that's all right.
Speaker 2 (00:55):
Well, this past week I had my doctor's appointment
and then I was down a day or two.
But yeah, thank you all forbeing so patient and supportive.
Down a day or two, but yeah,thank you all for being so
patient and supportive.
Speaker 1 (01:04):
And this week we're going to jump right into the
episode and topics because wehave a guest helper.
Speaker 2 (01:20):
Wendy, as well as a doctor to share information on a
new test.
Okay, but first a few quickshout outs to some of our
supporters.
Speaker 1 (01:27):
We've got matthew and miriam garaci, marcia treffman,
vicky setterberg, bonnie andrandy weber, d rickert and wendy
kogan and and as a reminder, weare not giving medical advice,
but rather sharing our open andhonest feelings and thoughts as
we live with louis body dementiaokay, uh, this is the episode
we've been telling y'all wascoming with a doctor from CNC
Life Science to talk about theSYN1 skin test.
Speaker 2 (01:50):
It's a new test to help in the diagnosis process of
LBD.
So please welcome to thepodcast Dr Ted Levine and also a
guest helper, Wendy Kogan,whose husband also has Lewy body
dementia.
All right, Winnie, can youshare a little about yourself
and then we'll get right intothe questions with Dr Levine.
Speaker 1 (02:08):
Yeah, and I'm just going to.
There is a typo.
It's CND Life Sciences.
That was on me.
Sorry, that was on me.
I knew it was CND.
I know you read it, I just readit wrong.
Okay, we're not even 30 secondsin and you messed up already,
what the hell.
And it's Todd Levine.
Does it say Todd, on your paper?
Speaker 2 (02:29):
Oh, yes, it does.
Speaker 1 (02:32):
It's people listening .
It's really early recording.
So, yeah, but our people areused to us this is the way it
rolls.
But anyway, wendy, you want tointroduce yourself.
Speaker 3 (02:46):
Yeah, yeah, thanks for having me on the show.
I really appreciate it.
I really appreciate thesepodcasts.
Overall Name's Wendy Kogan andmy husband's name is Jeff.
We live in Kansas City and myhusband was diagnosed with Lewy
body dementia about two yearsago when he was 65.
(03:09):
And just a little bit ofbackground on him, and I think,
as we do this podcast, you'rekind of going to get a feel, for
he was misdiagnosed severaltimes, which is often the case
with Lewy body dementia.
His first symptoms startedreally in 2007.
He had a sleep disorder,periodic limb movement disorder,
(03:31):
but in 2012, he got diagnosedwith a severe depression and
then in 2018, he got diagnosedwith bipolar All of a sudden in
his 60s.
He went on like manic buyingand selling sprees for two or
three years and this was in his60s.
(03:52):
Really weird when he got thatdiagnosis because for the most
part, bipolar starts, you know,in the 20s.
So that was kind of a firstclue.
Something was wrong.
I noticed that he continued tohave some mild cognitive
impairment and some visualspatial issues.
I'd go back to the psychiatristwho was treating him and say,
(04:16):
is it more than just bipolar?
And the psychiatrist keptreassuring me and saying, no,
you know, he's having someadditional mild cognitive
impairment just because of someof the medications he's on.
He was on lithium.
He had some issues after he hada special treatment called it
(04:38):
was a shock therapy where helost some cognition there too,
where he lost some cognitionthere too.
So they kept telling us to waitto see if he gets some of his
memory back.
He had forgotten, really, our10-year marriage, our eight-year
marriage.
We had been together 10 yearsbut anyway it really came to a
(05:00):
head in 2019.
We had gone to Florida for amonth.
He had a severe side, a severedrug reaction that put him in
full delirium and he was indelirium for about three weeks.
I finally said we're going tosee a neurologist.
We saw our first cognitiveneurologist.
They ran an MRI, they did anFDG-PAT and came back and said,
(05:25):
yep, he's got mild cognitiveimpairment, but we can't tell
you if it's Alzheimer's or Lewybody or what it is, and we
probably won't know for severalyears because right now he's not
having Parkinson's symptoms.
So you know, we probably.
Yeah, you know a lot offamilies don't want to know what
(05:46):
this is anyway and we'll knowin, you know, a matter of years.
Of course, I didn't buy that.
I used to be a nurse.
I went on you know Google and Iwas able to watch some of the
presentations that Mayo had donefor neurologists that talk
(06:06):
about different types ofdementia and I really thought my
husband seemed like he had Lewybody dementia, but he didn't
have hallucinations either.
He didn't have REM sleepbehavior but he had a lot of the
other things.
So I reached out to Dr Beauvaisat Mayo.
He did in fact suspect he hadLewy body.
We were able to do a virtualappointment.
(06:27):
The first appointment wasvirtual and he suspected it was.
Then we were able to go inperson.
My husband got a DAT scan andwas assessed.
The DAT scan was positive.
Now I thought if you have apositive DAT scan, that means
okay, yeah, it's definitely Lewybody or Parkinson's or MSA.
But you'll see something alittle twist later when we're
(06:51):
going through some questionsthat I also figured out about a
DAT scan.
It can also indicate adifferent type of dementia.
But in any event we were ableto get the testing done.
He was finally diagnosed withLewy body dementia.
He was he's part of theirbiomarker study.
(07:13):
So we really like being able togive back to science.
I had said at the time thatreally stuck with me is he said
people don't just all of asudden get bipolar in their 60s.
I mean, that just doesn'thappen.
And he said those cases aredefinitely a result of a
(07:37):
neurodegenerative disease likeLewy body dementia or FTD.
So that was our first clue thatsomething had majorly been
missed.
The other thing he said and hedid agree with me not all Lewy
body dementia patients even showParkinsonism.
Some actually go all the waythrough their life and don't get
(07:59):
that.
So we could have been waitinguntil he died if we were waiting
for that particular symptom forus to know what he had.
So once we got the rightdiagnosis, we were able to get
him on the right medicine forcognition, for psychiatric, for
sleep and, man, he reallyimproved.
The delirium totally gone,became functional again and our
(08:24):
quality of life significantlyimproved.
So, um man, I'm really excitedabout being able to have
biomarkers that can help othersnot have to go through all this
yeah, and I thanks for sharingthat wendy and I.
Speaker 1 (08:38):
I was uh got to meet wendy in person last weekend and
and meet her husband and whenyou hear what he went through
and that Curry and I always talkabout, the sooner someone gets
diagnosed, sure, there's nomedicines to cure it, but
there's medicines to help thesymptoms.
So I think that's why the factthat we always hear people
(09:02):
taking two to five years to getdiagnosed, that's what's driving
me and Kari to do this podcast,just kind of shouting at the
rooftops and sharing people'sstories and thankful.
And another reason we askedWendy to come on is because she,
her husband, had the test thatthe doctor's going to talk about
(09:23):
.
So thanks for sharing that.
Wendy and Dr Levine, can youintroduce yourself and tell us a
little bit about yourself andyour connection with CND Life
Sciences?
Speaker 4 (09:35):
Sure, yeah, so I'm Dr Todd Levine.
I'm a neurologist based inPhoenix, arizona, where I direct
a neurology department for ahealthcare system out here.
My subspecialty training withinneurology actually was not
movement disorders or cognitivedisorders, but was actually
neuromuscular disorders, whichis the subspecialty that studies
(09:58):
nerve and muscle in theperipheral nervous system, not
the central nervous system, inthe peripheral nervous system,
not the central nervous system.
And about 12 to 15 years agopeople began to publish
information on the ability tosee nerves inside the skin to
help in diagnosing some of theneuropathy, so people with
numbness and burning andtingling and pain sometimes.
(10:22):
All of our conventional testsdid not really yield a specific
diagnosis and so the folks atthe University of Minnesota and
Johns Hopkins really kind ofpioneered this test and so I
opened a lab about a decade agoto receive specimens from all
over the country to study thenerves, and that lab basically
(10:42):
looks at the nerves to saywhether they're healthy or not.
But it really got me into theconcept of how many nervous
system structures there are inthe skin, so autonomic
structures and sensorystructures and lots of really
interesting nerves in the skin.
And then about seven or eightyears ago my two other
co-founders, chris Gibbons andRoy Freeman, who are both at
(11:04):
Beth Israel in Boston.
They began to publish some workto say you could not only look
at the nerves in the skin butyou could actually look inside
the nerves of the skin and seewhat's going on inside of them.
And their earliest work reallyfocused on looking at this
protein called synuclein andwe're obviously going to talk a
lot about that during thepodcast.
(11:26):
But what's become clear is thatthere are a number of diseases
which people have traditionallythought may only exist in the
central nervous system, likeLewy body dementia, like
Parkinson's disease, where nowwe understand that these are
really full body diseases, thatthe damage that's occurring in
the central nervous system isactually occurring throughout
(11:47):
the entire body.
In the case of Parkinson'sdisease, it's fairly well
accepted now that the firstdamage may actually be out in
the body and it may take yearsfor that damage to move up into
the brain.
Examples of that may be 10years before someone has
Parkinson's disease, they haveconstipation because the nerves
(12:09):
to their intestines don't workvery well.
They start to have bladderdysfunction because the nerves
to their bladder don't work verywell, and so there's this
concept in all of these diseases.
Are these top-down, meaningthey start in the brain and
spread out to the body, or arethey bottom-up, meaning they
start out in the body and thenspread up to the brain?
(12:29):
So with that sort of concept, webegan to think that using the
skin may allow us to helpdiagnose these conditions in a
much more objective way.
And, wendy, you alluded to theterm which I use often but then
I tell myself I don't want touse, which is the term biomarker
.
So a biomarker means somethingthat you can measure as a
(12:50):
reflection of a disease.
What we are able to do isactually see the abnormal form
of the protein accumulating inthe skin.
So it's really pathology.
Just like you might look atautopsy in the brain and see a
Lewy body, we can look in theskin of a living person and see
the same accumulation of theproteins.
So with that, we founded C&DLife Sciences about six years
(13:14):
ago and we began doingcommercial testing throughout
the US about three years ago,just under three years.
Speaker 1 (13:22):
Yeah, this is very exciting when we heard about it.
We've been telling people inour support groups and posting
about the tests anytime we hearabout it.
Something that's going to helpto diagnose we share.
So I'm assuming you get thatall our listeners are aware that
(13:43):
Lewy body dementia is aneurodegenerative disease which
is part of a group ofprogressive conditions that
damage the nervous system, andso there we have a lot of people
that are seeking diagnosis,that are diagnosed, caregivers
and, like Dr Google, we all havebeen to Dr Google, you know to
(14:04):
help.
So the reason that we askedWendy to come on, because
clearly she has the medicalbackground but, wendy, I just
want to say you have the mostamazing way of explaining things
you know and because we were inour support group Saturday and
she was explaining about whatwere you doing with your fingers
(14:27):
.
Speaker 3 (14:28):
Aricep, I was explaining why that worked.
Yeah, why.
Speaker 1 (14:31):
Aricep worked, but anyway.
So that's why we brought Wendy,because just her introduction
tells you that.
You know, when I was with herlast weekend, I was just staring
at her.
She talked because I'm like,give me more, give me more
information.
She does our homework for us,but anyway.
So we're going to ask you somequestions about the actual test,
Dr Levine, and then we're goingto ask you some questions about
(14:51):
the actual test, Dr Levine, andthen we're going to ask Wendy
to help with some additionalquestions and, for our listeners
, we'll post the link to the CNDLife Sciences on our pages and
in the episode notes, just soyou know.
So, Dr Levine, here's the thing.
(15:12):
We've been telling everybodythat this podcast was coming.
So can you share with us whatthe SYN1 test is, as well as the
goals of CND Life Science?
Speaker 4 (15:24):
Sure.
So what we know in the nervoussystem is that there is this
protein called synuclein, andsynuclein is incredibly vital
for the normal function of yournervous system.
Unfortunately, even today, westill don't know exactly what it
does, but we know thatmutations in synuclein cause
(15:46):
Parkinson's disease.
We know that animals can'tsurvive without synuclein, so we
know that it's a very, veryimportant protein in the nervous
system.
What we also know for 100 yearsis that when you look inside
the brains of people who'vepassed away from Parkinson's
disease or Lewy body, what yousee are Lewy bodies, which is
(16:07):
named after the pathologist Lewywho discovered them.
And over the past 40 yearsyears, what became clear is that
that hallmark finding containsan accumulation of proteins and
not just a nucleon, but the mainprotein inside of a louis body
is synuclein.
And what seems to be thedifference between a normally
(16:28):
functioning synuclein proteinand an abnormal accumulation of
synuclein is the addition of alittle group called phosphorus,
so that chemical that you mighthave heard of phosphorus.
If you add that phosphorusgroup onto the end of the
synuclein protein, it causesthat synuclein protein to fold
(16:49):
incorrectly, and then what webelieve is the beginning of that
folding incorrectly then causesother proteins to fold
incorrectly, and that theory isnot just for Lewy body dementia
or Parkinson's.
That theory is true forAlzheimer's disease or
frontotemporal dementia.
It's just different proteins.
(17:09):
So in frontotemporal dementiait's a protein called TDP43.
In Alzheimer's disease, it'stwo proteins tau and amyloid.
So this accumulation ofproteins then builds up inside
of the nerves and eventuallydamages the nerves to the point
that they die.
So that is as best as weunderstand it in 2022.
(17:30):
What the SYN1 test allows is theability to look inside of the
nerves and to see if thatabnormal protein, the
phosphorylated synuclein, isstarting to accumulate inside
those nerves.
We believe that that is aprocess that doesn't occur in
normal people, and so thefinding of the abnormal protein,
(17:53):
the phosphorylated synuclein,tells us that there is a problem
with the synuclein systeminside of the nervous system.
So the SYN1 test is able to dothat by just using a small
little skin biopsy, just like adermatologist might do to look
at a rash or whatever.
So it doesn't require anystitches.
It takes literally two minutesto do and then it's sent to our
(18:22):
lab.
That's the process, and then wecan look inside the skin,
inside the nerves in the skin,and see if that abnormal protein
is there, so we can tell thedifference between a normal
nerve that contains normalsubnuclein and an abnormal nerve
that contains what we call thephosphorylated synuclein, which
we believe is pathologic orharmful to the nervous system.
Speaker 1 (18:42):
Well you hear that he's saying you're abnormal,
Curry.
I know right, it's official,it's official, I heard it right
here.
Speaker 2 (18:50):
Yeah, you're right, it's official.
I heard it right here.
Yeah, you're right, doctor.
The webpage states that theSYN1 test provides objective
pathological evidence to aid inthe diagnostic evaluation of
patients with clinical featuressuggestive of a synucleinopathy
similar to what you shared sofar synucleinopathy similar to
(19:16):
what you shared so far.
Speaker 1 (19:16):
So what's this can you share with us?
Uh, specific diseases includedin the neuro, neurodegenerative
synucleinopathies.
That's what it is.
Wendy told me this, mike, howdo you say that, wendy?
She's like opopathy.
Sorry, I didn't prep you curry,right um.
Speaker 4 (19:30):
So we think that there are five diseases with the
potential actually for a sixththat are all called
synucleinopathy.
So the most common isParkinson's disease, the second
is dementia with Lewy bodies,the third is a disease called
multiple system atrophy, thefourth is a disease called pure
(19:51):
autonomic failure and then thefifth is REM behavior disorder.
There was a recent paperlooking at a rare disease in the
Philippines called Lubog, inwhich people get dementia,
parkinson's and dystonia, and itwas a small number of patients,
but I think 85% of themactually had an abnormal SYN1
(20:15):
test, suggesting that thatdisease, which again fits into
the realm of Parkinsonism anddementia, may also be a
synucleinopathy.
Speaker 1 (20:27):
So what does an abnormal test identify, and can
this test distinguish betweenthe synucleinopathies you
mentioned?
And, if not, how wouldphysicians use the results of
the SYN1 skin test?
Speaker 4 (20:44):
Yeah.
So what the test tells us withcertainty is that there is an
accumulation of the abnormalform of synuclein, and so that
meets the definition of asynucleinopathy.
It's a challenge at the momentto say that we can definitively
separate out the five diseases,and even more so because, as
(21:09):
some of you may be familiar,some of these diseases may
evolve into other diseases.
So REM behavior disorder issort of the classic one here,
where many people with Lewy bodyor Parkinson's start with REM
behavior disorder five or 10years before they develop the
Lewy body or Parkinson's disease.
So you can imagine that ifwe're looking at the skin biopsy
(21:32):
, yes, we see the abnormalprotein throughout those five to
10 years, but it's difficult topredict what direction it's
going to go into.
So we are very actively tryingto pursue a number of important
clinical distinctions, and we'redoing this actually through two
multi-million dollar NIH grantsthat we were fortunate enough
(21:54):
to get.
So one we call the SYN1 study.
That one will be done probablyby the end of this year and we
think will really allow us in aprospective blinded way to
distinguish between thesynucleinopathies.
And then the second is a veryimportant study that we just
received an award in April ofthis year for that we call the
(22:16):
SIN-D study, which is actuallylooking at mild cognitive
impairment in the Alzheimer'sgroup versus mild cognitive
impairment in the Lewy bodygroup and asking whether we can
tell the difference betweenthose two and then also
following them prospectivelyover a couple of years to say
how does the biopsy change, howdoes the clinical picture change
(22:38):
.
So we're actively trying to beable to do that.
But to answer your questionright now, it really is a
combination of the clinicalfeatures with the biopsy and
just like any other x-ray or anyother test, even any other
biopsy you might do, theclinician always has to put it
(22:58):
together with what does thepatient look like and can this
test then help distinguishbetween possibilities?
Where this test is very helpfulis distinguishing between
synucleinopathies andnon-synucleinopathies.
So trying to distinguishAlzheimer's disease from Lewy
body, alzheimer's disease wouldbe normal, lewy body would be
(23:20):
abnormal.
Trying to distinguish somethinglike progressive supernuclear
palsy from Parkinson's disease,where PSP is due to tau, so the
SYN1 test would be normal andParkinson's obviously due to tau
, so the SYN1 test would benormal and Parkinson's obviously
due to synuclein.
So we are moving in thatdirection.
We can sometimes provide someguidance based on the pathology,
but we do believe that thepathology is going to be very
(23:42):
helpful.
Not 100% black and white,distinguishing between the five.
Really, the 100% black andwhite comes in synucleinopathy
versus non-synucleinopathy.
Okay, does that make sense?
Speaker 2 (23:55):
Yeah, it does, Dr Levine.
What are the advantages of thisspecific test?
Speaker 4 (24:05):
So there's a few advantages.
Again, if we think about whatyou'd want as a perfect test,
right?
You'd want to test number one,which is very sensitive and
specific, right, so it can pickup most people that have the
disease and it's not going isvery sensitive and specific,
right, so it can pick up mostpeople that have the disease and
it's not going to pick up falsepositives, right?
So we believe that oursensitivity and specificity is
(24:27):
greater than 95%, which is aboutas good as these types of tests
can get.
The second is that you'd want itto be easy for the patient.
So, for example, any of youthat have had a DAT scan know
that you have to go to thefacility, you have to get
injected, you have to waitseveral hours, you have to get
imaged.
It's a four, five, six hourprocess, whereas this test
(24:50):
really all in is about 15minutes.
So it's convenient for thepatient.
And then we'd want it to beaffordable patient.
And then we'd want it to beaffordable, and this test,
fortunately, has been well paidfor by insurances and by
Medicare, so that it's much moreaffordable.
Even the sticker price comparedto the sticker price of a DAT
(25:11):
scan, it's about one third theprice of a DAT scan.
So we think those are sort ofour main advantages is that it
can provide objective evidencefor the doctor, it's easy for
the patient and it's affordable.
So we're happy with thosepieces of our test right now
(25:38):
it's a pick on curry day becausewe're up early.
Speaker 1 (25:40):
Um, I'm gonna ask the doctor to explain the steps.
Someone would go through to getthe skin test, but I want to.
Did you hear him curry?
He said it's no big deal, justa little prick, and I heard that
I know we pick on curry becausehe's like I'm not gonna have a
spinal thingy, um, but anyway,uh, yeah, can you explain the
steps?
Uh, someone would go through toget this skin test uh.
Speaker 4 (26:05):
So for the most part just that the physician has to
believe that there's a reason todo the test, that there's some
diagnostic question.
And I sort of a little lesscommon, I think, probably for
your people that are listeningbut in the, the Parkinson's
world, for example, I like tosay you know, sometimes
Parkinson's is obvious, right?
(26:25):
So a person has a rest tremorand they shuffle and they're
slow and you give them themedicine and they get vastly
better.
You don't need a test, youdon't need a DAT scan, you don't
need the SYN1 test.
The clinicians already made thediagnosis, treated
appropriately.
We're good.
The SYN1 test is really forwhere there's diagnostic
confusion and for where we'retrying to provide a little more
information for the doctor tomake the best possible clinical
diagnosis.
(26:45):
So if the clinician believesthat this is a patient, that's
appropriate for that, we usuallyrun an authorization for the
insurance just so we can tellthe patient and the family what
to expect the out-of-pocket tobe.
They then come into thedoctor's office.
They don't have to stop anymedications, they don't have to
(27:07):
do anything special.
We take three biopsies, so onefrom the ankle, one from the
knee and one from the shoulder.
All three biopsies would takeabout 15 minutes, and then
that's sent off to us the sameday by the clinician In the lab.
The processing is very complex,so it is not like most pathology
Just very briefly in mostpathology like if you have a
(27:28):
breast biopsy, a colon biopsythey take that piece of tissue,
they put it in a piece ofplastic, they stick it in these
amazing machines that aremultimillion dollar machines and
20 minutes later you got abeautiful slide with your
section and the pathologist canread it.
That technique does not workfor what we're doing, so it is
literally everything is done byhand.
It's cut by hand.
(27:50):
We literally have little loopsthat move pieces of tissue that
are 1, 20th of a millimeterthick and they have to be
stained for days and days anddays.
The whole process in the labtakes about seven to eight days.
So we tell people that it wouldbe about three weeks from the
time that you have the biopsyfor us to process it in the lab
(28:13):
and then read it, issue thereport and get it back to your
doctor.
It's usually a little less, butif you plan on three weeks,
then nobody's disappointed.
Speaker 1 (28:21):
Yeah, yeah, we've heard the turnover is about
three weeks from people that hadthe test.
So when someone gets the report, can you share with us what the
report actually says?
And just for our listeners, ifyou go on the CND Life Sciences,
send one page, it'll show you asample of a report, which is
(28:41):
thank you for putting that upthere because it's yeah, I
thought that was pretty powerful.
Just see, I'm a visual learner,so that really helped me.
Speaker 4 (28:49):
Good, good.
So the report we basically lookat four pieces of information.
The first is is thephosphorylated synuclein protein
present?
That's the pathological form ofthe protein.
If first is, is thephosphorylated synuclein protein
present?
That's the pathological form ofthe protein.
If that is present, then thatis diagnostic of a
synucleinopathy.
So that's point number one.
Point number two is we look atthe nerves in the skin as well,
(29:11):
because we know that some ofthese conditions, some of the
five synucleinopathies, are morelikely to be associated with
neurodegeneration in theperiphery, not just in the brain
.
We know that that's true, forexample, in Parkinson's disease
at about 80%.
So we look at those nerves aswell because, again, we think as
we finish this study this yearit's going to be multiple pieces
(29:33):
of information from thepathology that give us the best
picture.
We also look for a proteincalled amyloid, as we said, that
can be found in lots of thesediseases as well.
And then we just look at aregular pathology picture to
make sure there's no cancerthere, rash there, inflammation
there as well.
We give every report containsthe patient's own pictures, so
(29:54):
they're not stock photos.
So we send back in the reportso that the clinician can go
over the pathology with thepatient and their family, so you
can see where this protein isaccumulating and you can see
whether the nerves aredeteriorating.
And then we give some specificsabout how many nerves, how many
sections.
(30:14):
That kind of information.
Speaker 2 (30:21):
Did that help Go ahead.
Speaker 1 (30:23):
Yeah, I'll jump in to help Kerry.
So you already talked about thecost of the test and covered by
Medicare and insurance.
Speaker 4 (30:40):
How would someone without insurance get the test?
So we do have a cash price.
Um, I can tell you the cashprice is about fourteen hundred
dollars for all three sites.
So it's not cheap, um, butagain, compared to a dat scam
that might be five to seventhousand dollars.
Um, it's cheaper.
Speaker 1 (30:50):
Um, we certainly have payment plans and all kinds of
ways to work with people ifthey're interested in doing that
as well yeah, thanks, thanksfor sharing that Because I know
and this next question we havelisteners for the podcast from
71 countries right now to date,and we have people from
(31:13):
different countries that attendour.
We do one, two, three, four,five support groups now a week.
So the people not from the USAwant to know is the test
available outside the USA?
Speaker 4 (31:29):
Great question, so complicated question.
So performing the biopsy isavailable anywhere.
That's easy.
There's a couple of challengesin getting it from other
countries.
So the first is some countrieshave fairly strict requirements
on what we can bring to them soour reagents, our test kits and
(31:53):
those types of things, things.
So in europe, for example, youhave to have something called a
ce marking if you want to beable to provide this.
We should have that by the endof the year and so we would be
able to receive from europebased on customs rules.
At that point.
Some countries don't have anycustoms rules and it's no
problem whatsoever.
The second challenge is thatwhen we do this test in the us
(32:23):
is that when we do this test inthe US and the doctor takes the
biopsy, it's put into somethingcalled a fixative and that
fixative helps fix the proteins.
That's what it's there for.
But it's harmful to the tissueif it's left in the fixative too
long.
So when it's sent back to usfrom the US, it's overnight.
We get it in 24 hours.
Everything's good.
Obviously, that's not going tohappen from Asia or Africa or
maybe even most of South America.
(32:44):
So we are doing researchstudies in Australia and Europe
and little bits of Asia.
When that happens, what thatmeans is that the clinician
takes the biopsy, they let thebiopsy sit in our fixative for
24 hours and then they wash itand put it in something called a
cryoprotective.
(33:05):
Once it's in the cryoprotective, you can't hurt it.
It's great.
So it's an extra step for thedifferent countries to be able
to ship to us and where we don'thave to worry about damaging
the tissue.
And then the third piece wouldjust be the cost, which would be
obviously it would have to becash from other countries
because we don't have insurancefrom there.
(33:26):
Now, having said that, inCanada, for example, canada has
health provinces and we are aparticipating provider with some
of those health provinces andare looking to become providers
with other health provinceswhere the health province would
just pay us directly and, likethe Canadian healthcare system,
is free to the patient.
I think we had one Canadianpatient who actually flew down
(33:47):
to the US and had the biopsydone in the US and then paid
cash.
So it's doable.
What I would say is, if anyonewanted to do this from another
country, just contact our lab.
We could figure out what therules are.
We could work with them and seeif there's any way to do it
work with their clinician.
So it's definitely doable.
I've always hoped that we couldprovide this worldwide, but
(34:10):
there are a few more complicatedsteps that go into place.
Speaker 1 (34:13):
Yeah, I have faith that it'll work out with other
countries, as you guys continueto work hard.
So we're going to stop here fora bit and when we come back
next week we're going to pick upwith Wendy asking some more of
(34:35):
the medical-based questions.
Speaker 2 (34:38):
Thank you again, Dr Levine, and to our guest helper,
Wendy Kogan.
Remember you can email us withsuggestions on what you'd like
us to discuss on future episodes, or you can ask any questions
you have, and we'll sure do ourbest to help get you the best
answer possible.
Speaker 1 (34:53):
And remember that Curry sometimes remembers to add
the links.
If you're interested in helpingus as a volunteer and advocate,
please send us an email atlouisbodyrollercoaster at
gmailcom, because the morepeople who reach out, the more
people we can help and if you'dlike to learn how you can be a
supporter of the podcast, pleasesee the episode notes, as we
(35:13):
post information on that there.
Speaker 2 (35:16):
Well folks, thanks again for joining us until.
Speaker 1 (35:18):
Until next week.
Speaker 2 (35:19):
This is Linda and Curry signing off.
Hello and welcome to our podcast about living on the
Lewy Body Roller Coaster apodcast for Lewy Body Dementia
patients and their families.
Presented by Lewy Body patientsand their families.
Speaker 2 (00:13):
You will hear firsthand the ups and downs and
twists and turns of Lewy BodyDementia From families directly
affected.
We'll share our support andexperiences on all things Lewy
Body.
Speaker 1 (00:25):
We're your hosts, Linda and Curry.
I have a loved one with LewyBody Dementia.
Speaker 2 (00:30):
And I am living with Lewy Body Dementia.
Speaker 1 (00:33):
Let's get started.
Welcome back podcast family.
Speaker 2 (00:43):
Yes, welcome back y'all.
Speaker 1 (00:45):
Just another quick shout out to everyone for your
continued support and patience.
We were good there for like twoweeks, curry, they came out on
time and then this past week,hiccup, but that's all right.
Speaker 2 (00:55):
Well, this past week I had my doctor's appointment
and then I was down a day or two.
But yeah, thank you all forbeing so patient and supportive.
Down a day or two, but yeah,thank you all for being so
patient and supportive.
Speaker 1 (01:04):
And this week we're going to jump right into the
episode and topics because wehave a guest helper.
Speaker 2 (01:20):
Wendy, as well as a doctor to share information on a
new test.
Okay, but first a few quickshout outs to some of our
supporters.
Speaker 1 (01:27):
We've got matthew and miriam garaci, marcia treffman,
vicky setterberg, bonnie andrandy weber, d rickert and wendy
kogan and and as a reminder, weare not giving medical advice,
but rather sharing our open andhonest feelings and thoughts as
we live with louis body dementiaokay, uh, this is the episode
we've been telling y'all wascoming with a doctor from CNC
Life Science to talk about theSYN1 skin test.
Speaker 2 (01:50):
It's a new test to help in the diagnosis process of
LBD.
So please welcome to thepodcast Dr Ted Levine and also a
guest helper, Wendy Kogan,whose husband also has Lewy body
dementia.
All right, Winnie, can youshare a little about yourself
and then we'll get right intothe questions with Dr Levine.
Speaker 1 (02:08):
Yeah, and I'm just going to.
There is a typo.
It's CND Life Sciences.
That was on me.
Sorry, that was on me.
I knew it was CND.
I know you read it, I just readit wrong.
Okay, we're not even 30 secondsin and you messed up already,
what the hell.
And it's Todd Levine.
Does it say Todd, on your paper?
Speaker 2 (02:29):
Oh, yes, it does.
Speaker 1 (02:32):
It's people listening .
It's really early recording.
So, yeah, but our people areused to us this is the way it
rolls.
But anyway, wendy, you want tointroduce yourself.
Speaker 3 (02:46):
Yeah, yeah, thanks for having me on the show.
I really appreciate it.
I really appreciate thesepodcasts.
Overall Name's Wendy Kogan andmy husband's name is Jeff.
We live in Kansas City and myhusband was diagnosed with Lewy
body dementia about two yearsago when he was 65.
(03:09):
And just a little bit ofbackground on him, and I think,
as we do this podcast, you'rekind of going to get a feel, for
he was misdiagnosed severaltimes, which is often the case
with Lewy body dementia.
His first symptoms startedreally in 2007.
He had a sleep disorder,periodic limb movement disorder,
(03:31):
but in 2012, he got diagnosedwith a severe depression and
then in 2018, he got diagnosedwith bipolar All of a sudden in
his 60s.
He went on like manic buyingand selling sprees for two or
three years and this was in his60s.
(03:52):
Really weird when he got thatdiagnosis because for the most
part, bipolar starts, you know,in the 20s.
So that was kind of a firstclue.
Something was wrong.
I noticed that he continued tohave some mild cognitive
impairment and some visualspatial issues.
I'd go back to the psychiatristwho was treating him and say,
(04:16):
is it more than just bipolar?
And the psychiatrist keptreassuring me and saying, no,
you know, he's having someadditional mild cognitive
impairment just because of someof the medications he's on.
He was on lithium.
He had some issues after he hada special treatment called it
(04:38):
was a shock therapy where helost some cognition there too,
where he lost some cognitionthere too.
So they kept telling us to waitto see if he gets some of his
memory back.
He had forgotten, really, our10-year marriage, our eight-year
marriage.
We had been together 10 yearsbut anyway it really came to a
(05:00):
head in 2019.
We had gone to Florida for amonth.
He had a severe side, a severedrug reaction that put him in
full delirium and he was indelirium for about three weeks.
I finally said we're going tosee a neurologist.
We saw our first cognitiveneurologist.
They ran an MRI, they did anFDG-PAT and came back and said,
(05:25):
yep, he's got mild cognitiveimpairment, but we can't tell
you if it's Alzheimer's or Lewybody or what it is, and we
probably won't know for severalyears because right now he's not
having Parkinson's symptoms.
So you know, we probably.
Yeah, you know a lot offamilies don't want to know what
(05:46):
this is anyway and we'll knowin, you know, a matter of years.
Of course, I didn't buy that.
I used to be a nurse.
I went on you know Google and Iwas able to watch some of the
presentations that Mayo had donefor neurologists that talk
(06:06):
about different types ofdementia and I really thought my
husband seemed like he had Lewybody dementia, but he didn't
have hallucinations either.
He didn't have REM sleepbehavior but he had a lot of the
other things.
So I reached out to Dr Beauvaisat Mayo.
He did in fact suspect he hadLewy body.
We were able to do a virtualappointment.
(06:27):
The first appointment wasvirtual and he suspected it was.
Then we were able to go inperson.
My husband got a DAT scan andwas assessed.
The DAT scan was positive.
Now I thought if you have apositive DAT scan, that means
okay, yeah, it's definitely Lewybody or Parkinson's or MSA.
But you'll see something alittle twist later when we're
(06:51):
going through some questionsthat I also figured out about a
DAT scan.
It can also indicate adifferent type of dementia.
But in any event we were ableto get the testing done.
He was finally diagnosed withLewy body dementia.
He was he's part of theirbiomarker study.
(07:13):
So we really like being able togive back to science.
I had said at the time thatreally stuck with me is he said
people don't just all of asudden get bipolar in their 60s.
I mean, that just doesn'thappen.
And he said those cases aredefinitely a result of a
(07:37):
neurodegenerative disease likeLewy body dementia or FTD.
So that was our first clue thatsomething had majorly been
missed.
The other thing he said and hedid agree with me not all Lewy
body dementia patients even showParkinsonism.
Some actually go all the waythrough their life and don't get
(07:59):
that.
So we could have been waitinguntil he died if we were waiting
for that particular symptom forus to know what he had.
So once we got the rightdiagnosis, we were able to get
him on the right medicine forcognition, for psychiatric, for
sleep and, man, he reallyimproved.
The delirium totally gone,became functional again and our
(08:24):
quality of life significantlyimproved.
So, um man, I'm really excitedabout being able to have
biomarkers that can help othersnot have to go through all this
yeah, and I thanks for sharingthat wendy and I.
Speaker 1 (08:38):
I was uh got to meet wendy in person last weekend and
and meet her husband and whenyou hear what he went through
and that Curry and I always talkabout, the sooner someone gets
diagnosed, sure, there's nomedicines to cure it, but
there's medicines to help thesymptoms.
So I think that's why the factthat we always hear people
(09:02):
taking two to five years to getdiagnosed, that's what's driving
me and Kari to do this podcast,just kind of shouting at the
rooftops and sharing people'sstories and thankful.
And another reason we askedWendy to come on is because she,
her husband, had the test thatthe doctor's going to talk about
(09:23):
.
So thanks for sharing that.
Wendy and Dr Levine, can youintroduce yourself and tell us a
little bit about yourself andyour connection with CND Life
Sciences?
Speaker 4 (09:35):
Sure, yeah, so I'm Dr Todd Levine.
I'm a neurologist based inPhoenix, arizona, where I direct
a neurology department for ahealthcare system out here.
My subspecialty training withinneurology actually was not
movement disorders or cognitivedisorders, but was actually
neuromuscular disorders, whichis the subspecialty that studies
(09:58):
nerve and muscle in theperipheral nervous system, not
the central nervous system, inthe peripheral nervous system,
not the central nervous system.
And about 12 to 15 years agopeople began to publish
information on the ability tosee nerves inside the skin to
help in diagnosing some of theneuropathy, so people with
numbness and burning andtingling and pain sometimes.
(10:22):
All of our conventional testsdid not really yield a specific
diagnosis and so the folks atthe University of Minnesota and
Johns Hopkins really kind ofpioneered this test and so I
opened a lab about a decade agoto receive specimens from all
over the country to study thenerves, and that lab basically
(10:42):
looks at the nerves to saywhether they're healthy or not.
But it really got me into theconcept of how many nervous
system structures there are inthe skin, so autonomic
structures and sensorystructures and lots of really
interesting nerves in the skin.
And then about seven or eightyears ago my two other
co-founders, chris Gibbons andRoy Freeman, who are both at
(11:04):
Beth Israel in Boston.
They began to publish some workto say you could not only look
at the nerves in the skin butyou could actually look inside
the nerves of the skin and seewhat's going on inside of them.
And their earliest work reallyfocused on looking at this
protein called synuclein andwe're obviously going to talk a
lot about that during thepodcast.
(11:26):
But what's become clear is thatthere are a number of diseases
which people have traditionallythought may only exist in the
central nervous system, likeLewy body dementia, like
Parkinson's disease, where nowwe understand that these are
really full body diseases, thatthe damage that's occurring in
the central nervous system isactually occurring throughout
(11:47):
the entire body.
In the case of Parkinson'sdisease, it's fairly well
accepted now that the firstdamage may actually be out in
the body and it may take yearsfor that damage to move up into
the brain.
Examples of that may be 10years before someone has
Parkinson's disease, they haveconstipation because the nerves
(12:09):
to their intestines don't workvery well.
They start to have bladderdysfunction because the nerves
to their bladder don't work verywell, and so there's this
concept in all of these diseases.
Are these top-down, meaningthey start in the brain and
spread out to the body, or arethey bottom-up, meaning they
start out in the body and thenspread up to the brain?
(12:29):
So with that sort of concept, webegan to think that using the
skin may allow us to helpdiagnose these conditions in a
much more objective way.
And, wendy, you alluded to theterm which I use often but then
I tell myself I don't want touse, which is the term biomarker
.
So a biomarker means somethingthat you can measure as a
(12:50):
reflection of a disease.
What we are able to do isactually see the abnormal form
of the protein accumulating inthe skin.
So it's really pathology.
Just like you might look atautopsy in the brain and see a
Lewy body, we can look in theskin of a living person and see
the same accumulation of theproteins.
So with that, we founded C&DLife Sciences about six years
(13:14):
ago and we began doingcommercial testing throughout
the US about three years ago,just under three years.
Speaker 1 (13:22):
Yeah, this is very exciting when we heard about it.
We've been telling people inour support groups and posting
about the tests anytime we hearabout it.
Something that's going to helpto diagnose we share.
So I'm assuming you get thatall our listeners are aware that
(13:43):
Lewy body dementia is aneurodegenerative disease which
is part of a group ofprogressive conditions that
damage the nervous system, andso there we have a lot of people
that are seeking diagnosis,that are diagnosed, caregivers
and, like Dr Google, we all havebeen to Dr Google, you know to
(14:04):
help.
So the reason that we askedWendy to come on, because
clearly she has the medicalbackground but, wendy, I just
want to say you have the mostamazing way of explaining things
you know and because we were inour support group Saturday and
she was explaining about whatwere you doing with your fingers
(14:27):
.
Speaker 3 (14:28):
Aricep, I was explaining why that worked.
Yeah, why.
Speaker 1 (14:31):
Aricep worked, but anyway.
So that's why we brought Wendy,because just her introduction
tells you that.
You know, when I was with herlast weekend, I was just staring
at her.
She talked because I'm like,give me more, give me more
information.
She does our homework for us,but anyway.
So we're going to ask you somequestions about the actual test,
Dr Levine, and then we're goingto ask you some questions about
(14:51):
the actual test, Dr Levine, andthen we're going to ask Wendy
to help with some additionalquestions and, for our listeners
, we'll post the link to the CNDLife Sciences on our pages and
in the episode notes, just soyou know.
So, Dr Levine, here's the thing.
(15:12):
We've been telling everybodythat this podcast was coming.
So can you share with us whatthe SYN1 test is, as well as the
goals of CND Life Science?
Speaker 4 (15:24):
Sure.
So what we know in the nervoussystem is that there is this
protein called synuclein, andsynuclein is incredibly vital
for the normal function of yournervous system.
Unfortunately, even today, westill don't know exactly what it
does, but we know thatmutations in synuclein cause
(15:46):
Parkinson's disease.
We know that animals can'tsurvive without synuclein, so we
know that it's a very, veryimportant protein in the nervous
system.
What we also know for 100 yearsis that when you look inside
the brains of people who'vepassed away from Parkinson's
disease or Lewy body, what yousee are Lewy bodies, which is
(16:07):
named after the pathologist Lewywho discovered them.
And over the past 40 yearsyears, what became clear is that
that hallmark finding containsan accumulation of proteins and
not just a nucleon, but the mainprotein inside of a louis body
is synuclein.
And what seems to be thedifference between a normally
(16:28):
functioning synuclein proteinand an abnormal accumulation of
synuclein is the addition of alittle group called phosphorus,
so that chemical that you mighthave heard of phosphorus.
If you add that phosphorusgroup onto the end of the
synuclein protein, it causesthat synuclein protein to fold
(16:49):
incorrectly, and then what webelieve is the beginning of that
folding incorrectly then causesother proteins to fold
incorrectly, and that theory isnot just for Lewy body dementia
or Parkinson's.
That theory is true forAlzheimer's disease or
frontotemporal dementia.
It's just different proteins.
(17:09):
So in frontotemporal dementiait's a protein called TDP43.
In Alzheimer's disease, it'stwo proteins tau and amyloid.
So this accumulation ofproteins then builds up inside
of the nerves and eventuallydamages the nerves to the point
that they die.
So that is as best as weunderstand it in 2022.
(17:30):
What the SYN1 test allows is theability to look inside of the
nerves and to see if thatabnormal protein, the
phosphorylated synuclein, isstarting to accumulate inside
those nerves.
We believe that that is aprocess that doesn't occur in
normal people, and so thefinding of the abnormal protein,
(17:53):
the phosphorylated synuclein,tells us that there is a problem
with the synuclein systeminside of the nervous system.
So the SYN1 test is able to dothat by just using a small
little skin biopsy, just like adermatologist might do to look
at a rash or whatever.
So it doesn't require anystitches.
It takes literally two minutesto do and then it's sent to our
(18:22):
lab.
That's the process, and then wecan look inside the skin,
inside the nerves in the skin,and see if that abnormal protein
is there, so we can tell thedifference between a normal
nerve that contains normalsubnuclein and an abnormal nerve
that contains what we call thephosphorylated synuclein, which
we believe is pathologic orharmful to the nervous system.
Speaker 1 (18:42):
Well you hear that he's saying you're abnormal,
Curry.
I know right, it's official,it's official, I heard it right
here.
Speaker 2 (18:50):
Yeah, you're right, it's official.
I heard it right here.
Yeah, you're right, doctor.
The webpage states that theSYN1 test provides objective
pathological evidence to aid inthe diagnostic evaluation of
patients with clinical featuressuggestive of a synucleinopathy
similar to what you shared sofar synucleinopathy similar to
(19:16):
what you shared so far.
Speaker 1 (19:16):
So what's this can you share with us?
Uh, specific diseases includedin the neuro, neurodegenerative
synucleinopathies.
That's what it is.
Wendy told me this, mike, howdo you say that, wendy?
She's like opopathy.
Sorry, I didn't prep you curry,right um.
Speaker 4 (19:30):
So we think that there are five diseases with the
potential actually for a sixththat are all called
synucleinopathy.
So the most common isParkinson's disease, the second
is dementia with Lewy bodies,the third is a disease called
multiple system atrophy, thefourth is a disease called pure
(19:51):
autonomic failure and then thefifth is REM behavior disorder.
There was a recent paperlooking at a rare disease in the
Philippines called Lubog, inwhich people get dementia,
parkinson's and dystonia, and itwas a small number of patients,
but I think 85% of themactually had an abnormal SYN1
(20:15):
test, suggesting that thatdisease, which again fits into
the realm of Parkinsonism anddementia, may also be a
synucleinopathy.
Speaker 1 (20:27):
So what does an abnormal test identify, and can
this test distinguish betweenthe synucleinopathies you
mentioned?
And, if not, how wouldphysicians use the results of
the SYN1 skin test?
Speaker 4 (20:44):
Yeah.
So what the test tells us withcertainty is that there is an
accumulation of the abnormalform of synuclein, and so that
meets the definition of asynucleinopathy.
It's a challenge at the momentto say that we can definitively
separate out the five diseases,and even more so because, as
(21:09):
some of you may be familiar,some of these diseases may
evolve into other diseases.
So REM behavior disorder issort of the classic one here,
where many people with Lewy bodyor Parkinson's start with REM
behavior disorder five or 10years before they develop the
Lewy body or Parkinson's disease.
So you can imagine that ifwe're looking at the skin biopsy
(21:32):
, yes, we see the abnormalprotein throughout those five to
10 years, but it's difficult topredict what direction it's
going to go into.
So we are very actively tryingto pursue a number of important
clinical distinctions, and we'redoing this actually through two
multi-million dollar NIH grantsthat we were fortunate enough
(21:54):
to get.
So one we call the SYN1 study.
That one will be done probablyby the end of this year and we
think will really allow us in aprospective blinded way to
distinguish between thesynucleinopathies.
And then the second is a veryimportant study that we just
received an award in April ofthis year for that we call the
(22:16):
SIN-D study, which is actuallylooking at mild cognitive
impairment in the Alzheimer'sgroup versus mild cognitive
impairment in the Lewy bodygroup and asking whether we can
tell the difference betweenthose two and then also
following them prospectivelyover a couple of years to say
how does the biopsy change, howdoes the clinical picture change
(22:38):
.
So we're actively trying to beable to do that.
But to answer your questionright now, it really is a
combination of the clinicalfeatures with the biopsy and
just like any other x-ray or anyother test, even any other
biopsy you might do, theclinician always has to put it
(22:58):
together with what does thepatient look like and can this
test then help distinguishbetween possibilities?
Where this test is very helpfulis distinguishing between
synucleinopathies andnon-synucleinopathies.
So trying to distinguishAlzheimer's disease from Lewy
body, alzheimer's disease wouldbe normal, lewy body would be
(23:20):
abnormal.
Trying to distinguish somethinglike progressive supernuclear
palsy from Parkinson's disease,where PSP is due to tau, so the
SYN1 test would be normal andParkinson's obviously due to tau
, so the SYN1 test would benormal and Parkinson's obviously
due to synuclein.
So we are moving in thatdirection.
We can sometimes provide someguidance based on the pathology,
but we do believe that thepathology is going to be very
(23:42):
helpful.
Not 100% black and white,distinguishing between the five.
Really, the 100% black andwhite comes in synucleinopathy
versus non-synucleinopathy.
Okay, does that make sense?
Speaker 2 (23:55):
Yeah, it does, Dr Levine.
What are the advantages of thisspecific test?
Speaker 4 (24:05):
So there's a few advantages.
Again, if we think about whatyou'd want as a perfect test,
right?
You'd want to test number one,which is very sensitive and
specific, right, so it can pickup most people that have the
disease and it's not going isvery sensitive and specific,
right, so it can pick up mostpeople that have the disease and
it's not going to pick up falsepositives, right?
So we believe that oursensitivity and specificity is
(24:27):
greater than 95%, which is aboutas good as these types of tests
can get.
The second is that you'd want itto be easy for the patient.
So, for example, any of youthat have had a DAT scan know
that you have to go to thefacility, you have to get
injected, you have to waitseveral hours, you have to get
imaged.
It's a four, five, six hourprocess, whereas this test
(24:50):
really all in is about 15minutes.
So it's convenient for thepatient.
And then we'd want it to beaffordable patient.
And then we'd want it to beaffordable, and this test,
fortunately, has been well paidfor by insurances and by
Medicare, so that it's much moreaffordable.
Even the sticker price comparedto the sticker price of a DAT
(25:11):
scan, it's about one third theprice of a DAT scan.
So we think those are sort ofour main advantages is that it
can provide objective evidencefor the doctor, it's easy for
the patient and it's affordable.
So we're happy with thosepieces of our test right now
(25:38):
it's a pick on curry day becausewe're up early.
Speaker 1 (25:40):
Um, I'm gonna ask the doctor to explain the steps.
Someone would go through to getthe skin test, but I want to.
Did you hear him curry?
He said it's no big deal, justa little prick, and I heard that
I know we pick on curry becausehe's like I'm not gonna have a
spinal thingy, um, but anyway,uh, yeah, can you explain the
steps?
Uh, someone would go through toget this skin test uh.
Speaker 4 (26:05):
So for the most part just that the physician has to
believe that there's a reason todo the test, that there's some
diagnostic question.
And I sort of a little lesscommon, I think, probably for
your people that are listeningbut in the, the Parkinson's
world, for example, I like tosay you know, sometimes
Parkinson's is obvious, right?
(26:25):
So a person has a rest tremorand they shuffle and they're
slow and you give them themedicine and they get vastly
better.
You don't need a test, youdon't need a DAT scan, you don't
need the SYN1 test.
The clinicians already made thediagnosis, treated
appropriately.
We're good.
The SYN1 test is really forwhere there's diagnostic
confusion and for where we'retrying to provide a little more
information for the doctor tomake the best possible clinical
diagnosis.
(26:45):
So if the clinician believesthat this is a patient, that's
appropriate for that, we usuallyrun an authorization for the
insurance just so we can tellthe patient and the family what
to expect the out-of-pocket tobe.
They then come into thedoctor's office.
They don't have to stop anymedications, they don't have to
(27:07):
do anything special.
We take three biopsies, so onefrom the ankle, one from the
knee and one from the shoulder.
All three biopsies would takeabout 15 minutes, and then
that's sent off to us the sameday by the clinician In the lab.
The processing is very complex,so it is not like most pathology
Just very briefly in mostpathology like if you have a
(27:28):
breast biopsy, a colon biopsythey take that piece of tissue,
they put it in a piece ofplastic, they stick it in these
amazing machines that aremultimillion dollar machines and
20 minutes later you got abeautiful slide with your
section and the pathologist canread it.
That technique does not workfor what we're doing, so it is
literally everything is done byhand.
It's cut by hand.
(27:50):
We literally have little loopsthat move pieces of tissue that
are 1, 20th of a millimeterthick and they have to be
stained for days and days anddays.
The whole process in the labtakes about seven to eight days.
So we tell people that it wouldbe about three weeks from the
time that you have the biopsyfor us to process it in the lab
(28:13):
and then read it, issue thereport and get it back to your
doctor.
It's usually a little less, butif you plan on three weeks,
then nobody's disappointed.
Speaker 1 (28:21):
Yeah, yeah, we've heard the turnover is about
three weeks from people that hadthe test.
So when someone gets the report, can you share with us what the
report actually says?
And just for our listeners, ifyou go on the CND Life Sciences,
send one page, it'll show you asample of a report, which is
(28:41):
thank you for putting that upthere because it's yeah, I
thought that was pretty powerful.
Just see, I'm a visual learner,so that really helped me.
Speaker 4 (28:49):
Good, good.
So the report we basically lookat four pieces of information.
The first is is thephosphorylated synuclein protein
present?
That's the pathological form ofthe protein.
If first is, is thephosphorylated synuclein protein
present?
That's the pathological form ofthe protein.
If that is present, then thatis diagnostic of a
synucleinopathy.
So that's point number one.
Point number two is we look atthe nerves in the skin as well,
(29:11):
because we know that some ofthese conditions, some of the
five synucleinopathies, are morelikely to be associated with
neurodegeneration in theperiphery, not just in the brain
.
We know that that's true, forexample, in Parkinson's disease
at about 80%.
So we look at those nerves aswell because, again, we think as
we finish this study this yearit's going to be multiple pieces
(29:33):
of information from thepathology that give us the best
picture.
We also look for a proteincalled amyloid, as we said, that
can be found in lots of thesediseases as well.
And then we just look at aregular pathology picture to
make sure there's no cancerthere, rash there, inflammation
there as well.
We give every report containsthe patient's own pictures, so
(29:54):
they're not stock photos.
So we send back in the reportso that the clinician can go
over the pathology with thepatient and their family, so you
can see where this protein isaccumulating and you can see
whether the nerves aredeteriorating.
And then we give some specificsabout how many nerves, how many
sections.
(30:14):
That kind of information.
Speaker 2 (30:21):
Did that help Go ahead.
Speaker 1 (30:23):
Yeah, I'll jump in to help Kerry.
So you already talked about thecost of the test and covered by
Medicare and insurance.
Speaker 4 (30:40):
How would someone without insurance get the test?
So we do have a cash price.
Um, I can tell you the cashprice is about fourteen hundred
dollars for all three sites.
So it's not cheap, um, butagain, compared to a dat scam
that might be five to seventhousand dollars.
Um, it's cheaper.
Speaker 1 (30:50):
Um, we certainly have payment plans and all kinds of
ways to work with people ifthey're interested in doing that
as well yeah, thanks, thanksfor sharing that Because I know
and this next question we havelisteners for the podcast from
71 countries right now to date,and we have people from
(31:13):
different countries that attendour.
We do one, two, three, four,five support groups now a week.
So the people not from the USAwant to know is the test
available outside the USA?
Speaker 4 (31:29):
Great question, so complicated question.
So performing the biopsy isavailable anywhere.
That's easy.
There's a couple of challengesin getting it from other
countries.
So the first is some countrieshave fairly strict requirements
on what we can bring to them soour reagents, our test kits and
(31:53):
those types of things, things.
So in europe, for example, youhave to have something called a
ce marking if you want to beable to provide this.
We should have that by the endof the year and so we would be
able to receive from europebased on customs rules.
At that point.
Some countries don't have anycustoms rules and it's no
problem whatsoever.
The second challenge is thatwhen we do this test in the us
(32:23):
is that when we do this test inthe US and the doctor takes the
biopsy, it's put into somethingcalled a fixative and that
fixative helps fix the proteins.
That's what it's there for.
But it's harmful to the tissueif it's left in the fixative too
long.
So when it's sent back to usfrom the US, it's overnight.
We get it in 24 hours.
Everything's good.
Obviously, that's not going tohappen from Asia or Africa or
maybe even most of South America.
(32:44):
So we are doing researchstudies in Australia and Europe
and little bits of Asia.
When that happens, what thatmeans is that the clinician
takes the biopsy, they let thebiopsy sit in our fixative for
24 hours and then they wash itand put it in something called a
cryoprotective.
(33:05):
Once it's in the cryoprotective, you can't hurt it.
It's great.
So it's an extra step for thedifferent countries to be able
to ship to us and where we don'thave to worry about damaging
the tissue.
And then the third piece wouldjust be the cost, which would be
obviously it would have to becash from other countries
because we don't have insurancefrom there.
(33:26):
Now, having said that, inCanada, for example, canada has
health provinces and we are aparticipating provider with some
of those health provinces andare looking to become providers
with other health provinceswhere the health province would
just pay us directly and, likethe Canadian healthcare system,
is free to the patient.
I think we had one Canadianpatient who actually flew down
(33:47):
to the US and had the biopsydone in the US and then paid
cash.
So it's doable.
What I would say is, if anyonewanted to do this from another
country, just contact our lab.
We could figure out what therules are.
We could work with them and seeif there's any way to do it
work with their clinician.
So it's definitely doable.
I've always hoped that we couldprovide this worldwide, but
(34:10):
there are a few more complicatedsteps that go into place.
Speaker 1 (34:13):
Yeah, I have faith that it'll work out with other
countries, as you guys continueto work hard.
So we're going to stop here fora bit and when we come back
next week we're going to pick upwith Wendy asking some more of
(34:35):
the medical-based questions.
Speaker 2 (34:38):
Thank you again, Dr Levine, and to our guest helper,
Wendy Kogan.
Remember you can email us withsuggestions on what you'd like
us to discuss on future episodes, or you can ask any questions
you have, and we'll sure do ourbest to help get you the best
answer possible.
Speaker 1 (34:53):
And remember that Curry sometimes remembers to add
the links.
If you're interested in helpingus as a volunteer and advocate,
please send us an email atlouisbodyrollercoaster at
gmailcom, because the morepeople who reach out, the more
people we can help and if you'dlike to learn how you can be a
supporter of the podcast, pleasesee the episode notes, as we
(35:13):
post information on that there.
Speaker 2 (35:16):
Well folks, thanks again for joining us until.
Speaker 1 (35:18):
Until next week.
Speaker 2 (35:19):
This is Linda and Curry signing off.
Popular Podcasts
Stuff You Should Know
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Follow now to get the latest episodes of Dateline NBC completely free, or subscribe to Dateline Premium for ad-free listening and exclusive bonus content: DatelinePremium.com
Las Culturistas with Matt Rogers and Bowen Yang
Ding dong! Join your culture consultants, Matt Rogers and Bowen Yang, on an unforgettable journey into the beating heart of CULTURE. Alongside sizzling special guests, they GET INTO the hottest pop-culture moments of the day and the formative cultural experiences that turned them into Culturistas. Produced by the Big Money Players Network and iHeartRadio.