New Blood Test To Identify People At Risk Of Developing Alzheimer's Symptoms Will Be Used In Clinical Trial Aiming To Prevent Memory Loss
For those of you who might be interested in this study, here's an excerpt from the news release link above:
FYI: All clinical trials involve a visit for explanation of the trial and discussion of a lengthy consent form usually with a brief cognitive test. The next step, considered the first Screening visit, can last 3-5 hours and includes cognitive tests, blood tests, health history and medications list, a brief neurological or physical exam and an EKG, and participant and study partner questionnaires. All that is used to see if you meet the health and cognitive requirements, BEFORE scheduling an Amyloid PET scan, MRI and possibly tau PET scan."Blood-based screening is a giant leap forward in detecting changes in the brain among people who do not yet show memory loss symptoms," said Reisa Sperling, MD, director of the Center for Alzheimer Research and Treatment at Brigham and Women's Hospital, Harvard Medical School and co-principal investigator for the AHEAD Study. "New blood test technology can help identify those more likely to have Alzheimer's disease changes in their brains, which enables them to enroll in prevention or treatment trials as early as possible. This is a remarkable achievement that may lead to detecting and treating Alzheimer's much earlier, and hopefully one day, preventing the memory loss associated with this devastating disease."
Funded by the National Institutes of Health (NIH) and Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd., the AHEAD Study is enrolling people between the ages of 55 and 80 to test whether removing amyloid plaques in the brain can delay or prevent the onset of Alzheimer's symptoms. The study will enroll 1,165 participants from North America, with research centers in 75 U.S. and Canadian communities. Researchers believe their use of a screening blood test will lower barriers to participating in clinical trials, especially among communities of color, which are historically underrepresented in Alzheimer's trials.
Study locations and eligibility requirements can be found at AHEAD Study
Using a blood test FIRST to find those most likely to be amyloid positive on a PET scan reduces the time burden on the 75% or so of people who typically don't have amyloid beta if cognitively unimpaired and promotes access in rural, diverse and under-served communities. More diversity in participants means more knowledge of the factors that affect responses to drugs in different groups, at different ages, genders and stages of prevention.
At the 2021 CTAD conference last week, Dr. Reisa Sperling showed a chart of those screened so far for the AHEAD studies by ApoE status (ApoE 2/2, 2/3, 2/4, 3/3, 3/4, 4/4). The total of 304 ApoE4 carriers were almost perfectly divided between amyloid positive (153) and amyloid negative (151). BUT ApoE4 carriers were only 46.1% of all those screened, yet were 77% of the amyloid positive group!. Those most likely to have amyloid beta were above the age of 65.
[Full disclosure: I am an unpaid member of the Research Participant Advisory Board at the Alzheimer's Clinical Trial Consortium, an NIH-funded effort to improve AD clinical trials. The AHEAD studies of BAN2401 (lecanemab) are one of the public/private partnerships coordinated by ACTC. The Advisory Board's role is to "Provide guidance on study design including the following areas: ethical considerations, disclosure of personal and study research results, privacy, recruitment approaches that engage diverse communities and increase trial generalizability, burden for participants and study partners, and selection of therapeutics, balancing risk and potential benefit..." In other words, I'm glad to help anyone interested in info on clinical trials, but not on commission to find folks! ]