A Game-Changing Approval by the FDA for Diagnosing Alzheimer’s Disease!

In today’s episode, Lisa shares the Alzheimer’s Association’s recent announcement about the FDA approving the first simple blood test for diagnosing Alzheimer’s disease. This announcement marks a significant step in Alzheimer’s disease diagnosis. Find out the details and what this finally means for earlier detection.  You definitely won’t want to miss this important episode! Additionally, Lisa discusses the top 10 challenges that individuals face with Alzheimer’s disease to help family members and caregivers recognize some of the more common symptoms.

Mentioned Resources:

Alz.org, May 16, 2025

About the Host:

Author Lisa Skinner is a behavioral specialist with expertise in Alzheimer’s disease and related dementia. In her 30+year career working with family members and caregivers, Lisa has taught them how to successfully navigate the many challenges that accompany this heartbreaking disease. Lisa is both a Certified Dementia Practitioner and is also a certified dementia care trainer through the Alzheimer’s Association. She also holds a degree in Human Behavior.

Her latest book, “Truth, Lies & Alzheimer’s – Its Secret Faces” continues Lisa’s quest of working with dementia-related illnesses and teaching families and caregivers how to better understand the daunting challenges of brain disease. Her #1 Best-seller book “Not All Who Wander Need Be Lost,” was written at their urging. As someone who has had eight family members diagnosed with dementia, Lisa Skinner has found her calling in helping others through the struggle so they can have a better-quality relationship with their loved ones through education and through her workshops on counter-intuitive solutions and tools to help people effectively manage the symptoms of brain disease. Lisa Skinner has appeared on many national and regional media broadcasts. Lisa helps explain behaviors caused by dementia, encourages those who feel burdened, and gives practical advice for how to respond.

So many people today are heavily impacted by Alzheimer's disease and related dementia. The Alzheimer's Association and the World Health Organization have projected that the number of people who will develop Alzheimer's disease by the year 2050 worldwide will triple if a treatment or cure is not found. Society is not prepared to care for the projected increase of people who will develop this devastating disease. In her 30 years of working with family members and caregivers who suffer from dementia, Lisa has recognized how little people really understand the complexities of what living with this disease is really like. For Lisa, it starts with knowledge, education, and training.

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Episode Transcript

Lisa Skinner (00:01):
Lisa, Hi everyone. Welcome to another brand new episode of the truth lies and Alzheimer's show. I'm Lisa Skinner, your host. I'm so glad to have you here with me today, because actually, I have a really game changing announcement to tell you about I am just really thrilled, and it's pretty significant. I would even go so far as to call it a new step for mankind when it comes to Alzheimer's disease. So what's happened is that the US Food and Drug Administration, the FDA, has cleared the very first blood test to aid in diagnosis of Alzheimer's disease. This test detects amyloid plaques, which, as we know, is a hallmark of Alzheimer's disease. And they're they're able to do this through a very simple blood draw, making it less invasive than other more commonly used diagnostic tools. Now the Alzheimer's Association, just as recently as May 16, issued their very first statement on the fact that the FDA just cleared this blood test for use. Today marks another important step in Alzheimer's disease diagnosis, said Maria Carrillo, PhD, the Alzheimer's Association Chief Science Officer and medical affairs lead. She continues to go and goes on to say, for too long, Americans have struggled to get a simple and accurate diagnosis with today's action by the FDA, we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier, while there is no single standalone test to diagnose Alzheimer's disease today, including this newly approved test, the blood testing can still be an important piece of the diagnostic process. Currently, physicians primarily use other more well established diagnostic tools combined with medical history, neurological exams, cognitive and functional assessments, brain imaging, spinal fluid analysis and increasingly, blood tests to make an accurate diagnosis and to understand which patients are eligible for a true approved treatments. Now, according to the FDA, this blood test, which is called the loopy pulse, G, P, T, A, u2, 17, B is for the early detection of amyloid plaques associated with Alzheimer's disease in adult patients age 55 years and older, exhibiting signs and symptoms of the disease, and this is What we've been striving for for decades is something that can help us diagnose, make an earlier diagnosis, and therefore help us with earlier interventions. There are a variety of laboratory developed tests on the market that can be used to detect blood based biomarkers associated with Alzheimer's disease. This is the first that has been cleared by the FDA for use. Yay. For many years, blood tests have been used in clinical trials, and increasingly they are being used by specialists in clinical settings, often as a first pass detection tool followed by additional testing. Blood based biomarkers are reshaping how we identify and understand Alzheimer's disease. Continued. Carrillo at the same time, there are important questions for healthcare professionals to consider, in particular, who should be tested and when the Alzheimer's Association is leading the development of Clinical Practice Guide. Guidelines for the use of blood biomarker tests in specialty care settings, which will be debuted this summer at the Alzheimer's Association International Conference, also known as the aaic, which is taking place July 27 to July, 31, of this year in Toronto, it's both in person and online. The first iteration of the clinical practice guidelines will provide evidence based recommendations for specialists to help guide them through the decision making process around who should be tested and when. In the meantime, the association urges providers to refer to the 2022 appropriate use recommendations for blood tests in clinical practice and trial settings in the 2025 Alzheimer's disease facts and figures. Special Report, it found that nearly four in five Americans would want to know if they had Alzheimer's disease before it impacted their lives. Specifically, 91% of Americans say they would want to take this simple blood test if it were available access to early treatment and care is the main reason cited for wanting to take this simple test, this interest in early diagnosis and treatment, highlights how very important it is that we keep advancing towards diagnostic testing that is Simple to administer and widely available. Ms Carrillo said this is the latest step toward better diagnosis and eventual treatment of Alzheimer's disease made possible by historic investment in Alzheimer's and dementia research by the National Institutes of Health, the Alzheimer's Association and and other private entities, and as a result of this increased investment, scientists have now been able to work at a more rapid pace to advance basic disease knowledge, identify ways to reduce risk, uncover new biomarkers for early diagnosis and drug targeting and develop disease modifying treatments. At least we're going forward in a positive direction. So just in case, a lot of you aren't that familiar with the Alzheimer's Association. I just want to mention that they are a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Their mission is to lead the way to end Alzheimer's disease and all other diseases that cause dementia, and they're doing this by accelerating global research, driving risk reduction and early detection and maximizing quality care and support their website, if you want to take a tour around, their website is alz.org I also today want to remind everybody that the World Heart Health Organization and the Alzheimer's Association is preparing us for the Alzheimer's tsunami. That's what I call it, that's coming. They've been projecting for the last several years that by the year 2050, the number of people who are expected to develop Alzheimer's disease, if a cure or a treatment is not found, will nearly triple worldwide from the number of people who are living with it today. Now think about that for a second. 2050 that's only 25 years away to have the number of people who will develop Alzheimer's disease nearly triple in that period of time.

(09:54):
And I've said this before. As a society, we are. Not even remotely prepared to care for that number of people who are expected to develop Alzheimer's disease. So bottom line, what that means is, if your family has not yet been touched by Alzheimer's disease. I think it's pretty clear that the chances that your family will at some point in the future be faced with a loved one or caring for somebody with Alzheimer's disease is very high, and I want nothing more than to help you be prepared for it, if it does, and that starts with knowledge and education and a set of skills, a set of tools. So I want to remind you, just so you will be prepared and know what to look for. These are the top 10 challenges that individuals face with Alzheimer's disease. Number one is memory loss that includes difficulty remembering recent events, conversations and names. Those are often the very first signs of Alzheimer's disease. Number two, having difficulty with familiar tasks, for example, struggling to complete routine tasks that were once familiar, like using a phone or operating home appliances, those very simple, basic tech tasks that people have been performing for decades all of a sudden become either very difficult or next to impossible, so that's something to look for. They also develop language problems, which means they could display trouble finding the right words in a sentence, understanding conversations or following along in discussions. They also become disoriented, which would look like losing track of dates, the seasons in the passage of time. Individuals may also become lost in very familiar places. They develop impaired judgment, which means they have a decreased ability to make decisions to judge distances or recognize safety hazards. They start misplacing things. They frequently lose items and do not recall where they put them, keeping them from being able to retrace their steps to find them, and then, unfortunately, a lot of times, because they lose the ability to to remember where they put something, they oftentimes accuse their caregivers or their family members of taking their belongings. You'll also see throughout the progression of Alzheimer's disease and dementia, you'll notice changes in moods and changes in their behaviors. So what that could look like is they'll experience mood swings Just out of nowhere. They'll seem depressed. They'll withdraw socially. They'll show a distrust, or express a distrust in others. Their irritability could significantly increase, and their aggression can significantly increase. These are all things to recognize and to look for. They also will have difficulty with completing complex tasks or even doing complex tasks, you'll see challenges in planning, organizing, following instructions and dealing with numbers, and then They lose their visual and spatial abilities. Those become impaired, and that means that they'll now have difficulty reading, judging distances, determining color or contrast, and all these things can lead to problems with just function. Being on a daily basis, and also with driving, become extremely dangerous. And then finally, they do tend to withdraw from social activities. They lose interest in hobbies, in social activities and other engagements. And these challenges, obviously can vary greatly from person to person, and may change over the course of the disease as it progresses. So therefore it's very important for caregivers and family members to be aware of these challenges so you can provide the appropriate support and care and also get them under the care of their physicians. So I wanted to share that with you today as well, just as a reminder, because the number of people that we're being told are going to develop Alzheimer's disease in the next 25 years is mind blowing. So that'll conclude this episode of today's truth lies and Alzheimer's show. I'm Lisa Skinner, your host, I hope, as always, you find a lot of value in the information I bring to you each week, and we'll continue to do so, and I hope you all continue to show up and benefit from a lot of this information that I do bring to you each week, so have a great rest of your week. Thanks again for sharing part of your day here with me, and I look forward to having you back next week. Take care for now. Bye, bye. You.