Contributed by Joshua Grill, PhD and David Sultzer, MD
A recent article in STAT highlights potential safety risks for anti-amyloid therapies, the frequent subject of postings in the UCI MIND blog. The focus of the article is on one patient who died after taking the anti-amyloid antibody lecanemab, a drug that was recently announced to have positive results in a Phase 3 clinical trial and is the treatment being tested in the AHEAD Study ongoing at UCI MIND and elsewhere. The patient experienced bleeding in the brain.
As described in the article, the case was complicated but potentially important. The individual had symptomatic Alzheimer’s disease (Mild Cognitive Impairment or mild dementia) and a series of health issues including falls and heart attack. It is not yet known whether the individual had been randomized to drug or placebo in the main clinical trial; they passed away after taking the active treatment while participating in an open-label extension to that study. Particular attention was paid to the fact that the individual was on a blood thinner medication, raising the possibility that the risk of the side effects for anti-amyloid antibody treatments may be higher for people taking these medications. This potential risk will be examined carefully in the analysis of the study’s results, along with the evaluation for treatment benefits. The findings will be clearly important to future studies of lecanemab and other drugs in this class.
Alzheimer’s disease is a fatal neurodegenerative disease and a source of tremendous personal and public burden. All treatments have risks. Individuals enrolling in clinical trials must decide whether the potential benefits of participation are worth the potential risks. Clinical trials represent the best and more rigorous opportunity to understand risk profile, though complete understanding can take several years of use in clinical practice. New and improved treatments for Alzheimer’s disease, like all medications, will certainly have some safety risks. The field must balance these risks, particularly ensuring transparency and informed consent among participants, while being unrelenting in pursuit of improved options for patients and their families.