Investigational Alzheimer’s Blood Tests Have “Revolutionary Potential”

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News from the Memory and Aging Program at Butler Hospital

August 1, 2022

 

Stephen Salloway, MD, MS, of Butler Hospital, Brown University and Co-Author of the Recommendations Shares Insights on Future Potential

 

 Recommendations for the use of investigational Alzheimer’s “blood tests” were released yesterday at the Alzheimer’s Association International Conference® (AAIC®) and published in an article in Alzheimer’s & Dementia: Journal of the Alzheimer’s Association. The recommendations were made by a global workgroup convened by the Alzheimer’s Association which included leading Alzheimer’s disease researcher Stephen Salloway, MD, MS. Salloway is founder of the Memory and Aging Program at Butler Hospital and is also the Martin M. Zucker Professor of Psychiatry and Human Behavior, Professor of Neurology, and Associate Director of the Center for Alzheimer’s Disease Research at Brown University.

In the article, lead author Oskar Hansson, M.D., Ph.D., director of the Center for Neurodegenerative Diseases at Lund University and Skane University Hospital, Malmo, Sweden along with Salloway and other co-authors, state that although Alzheimer’s disease blood biomarkers (BBMs) are not yet ready for widespread use, they are important and valuable for current research trials as well as cautious initial use in specialized memory clinics, and may revolutionize the diagnosis of Alzheimer’s in the future.

“With additional study and evaluation, blood biomarkers truly could revolutionize the diagnosis of Alzheimer’s and other forms of dementia,” Dr. Salloway says. “In particular, they may prove to be an easy, inexpensive and relatively painless test for the disease that could be administered by primary care providers as part of routine physical exams. That’s extremely significant because it could potentially identify developing disease even decades before symptoms begin, allowing for early treatment that could delay the onset of symptoms and perhaps even reduce their severity when they do occur.”

 

Dr. Salloway says that further development and implementation of BBMs alongside further development of potential treatments for Alzheimer’s disease, could modify the course of Alzheimer’s disease for millions of people around the world.

“The more we learn from Alzheimer’s research, the more it has become clear that prevention and early intervention are the keys to defeating this disease,” Dr. Salloway says. “We’re likely decades away from having the knowledge and technology to try and reverse the disease once it has become advanced, if that ever becomes possible at all. But the ability to identify it in its earliest stages and develop disease-modifying drugs that prevent life-altering symptoms may be closer than we think.”

According to the workgroup, about 25-30% of patients with a clinical diagnosis of Alzheimer’s dementia are misdiagnosed when assessed at specialized dementia clinics, and the accuracy of clinical diagnosis is similar or even lower for other dementias, including frontotemporal dementia, dementia with Lewy bodies and vascular dementia. In fact, in most countries, most patients with cognitive or behavioral symptoms are managed in primary care where the misdiagnosis is even higher. The problem is especially acute in the earliest stages of the disease.

According to the article, BBMs show “great promise” — especially markers for Alzheimer’s-related brain changes related to nerve cell damage/death, and tau and beta amyloid accumulation (proteins in the brain believed to be related to the development of Alzheimer’s) — for “future use in both clinical practice and trials. However, few prospective studies have investigated the implementation of such BBMs in more heterogeneous populations.”

The workgroup points out that no studies have extensively evaluated BBMs for neurodegenerative diseases in primary care, and calls for “well-performed BBM studies in diverse primary care populations.” Such studies should also evaluate the impact of BBMs on diagnostic accuracy and change in patient management.

There are current uses for Alzheimer’s BBMs, however, the workgroup reported. For example, they “recommend use of BBMs as (pre-)screeners to identify individuals likely to have Alzheimer’s pathological changes for inclusion in trials evaluating disease-modifying therapies, provided Alzheimer’s status is confirmed with positron emission tomography (PET) or cerebrospinal fluid (CSF) testing.”

BBMs can be used as exploratory outcomes in most clinical trials in Alzheimer’s and other neurodegenerative dementias. In non-Alzheimer’s trials, BBMs can be used to identify patients who likely have Alzheimer’s-related brain changes, if that is a condition of exclusion from the study.

Full details of the workgroup’s recommendations are available in their article published in Alzheimer’s & Dementia: Journal of the Alzheimer’s Association, available online at
alz-journals.onlinelibrary.wiley.com.

 

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