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

Are you caring for a loved one with dementia? You don't have to figure this out all on your own. Welcome to Truth, Lies Alzheimer's, the show that helps you reimagine a new relationship with your loved one, a relationship a little more free of stress and anxiety. Join host Lisa Skinner and her 30+ years of experience as she guides you on a new path to a better relationship with those you care for. Here's Lisa.

Hi everyone, welcome to another brand new episode of the Truth, Lies Alzheimer's Show. I'm Lisa Skinner, your host. I'm so glad to have you here with me today because I 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 U.S. 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 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 16th, 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 Lumpy Pulse GPTAU217B, 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 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 27th to July 31st 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 4 in 5 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 a 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 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 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. 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'll be prepared and know what to look for. These are the top 10 challenges that individuals face with Alzheimer's disease. Number 1 is memory loss. That includes difficulty remembering recent events, conversations, and names. Those are often the very first signs of Alzheimer's disease. Number 2, 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 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, and 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. Uh, 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 functioning 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 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 will 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.

Thank you for listening to Truth, Lies Alzheimer's. We hope you found something in today's episode that helps. We understand that caring for a loved one with dementia can be the challenge of a lifetime, but you don't have to do it alone. If you're ready for exclusive access to even more great content and resources, head on over to Facebook and join Lisa Skinner's Minding Dementia support group. We're a community of like-minded caregivers, and we're here to help.