Landmark FDA approvals of anti-amyloid drugs like lecanemab and donanemab may not offer hope for individuals with Down syndrome who develop Alzheimer’s disease (AD). A recent study examining post-mortem brain tissue from individuals with AD and Down syndrome has revealed significant safety concerns regarding the use of these drugs in this specific population.
The research indicated that the anti-amyloid drugs extensively bound to brain blood vessels. This is particularly concerning given that people with Down syndrome have the highest prevalence for developing AD, with approximately 30% being diagnosed by their 50s and having a greater than 90% chance of developing dementia from AD in their lifetimes.
Despite the high risk, individuals with Down syndrome have historically been excluded from AD research. Of the more than 18,000 people who participated in clinical trials for drugs like lecanemab and donanemab, none had Down syndrome. This exclusion raises questions about the applicability and safety of these treatments for this vulnerable population.
The findings underscore the urgent need for clinical trials specifically designed for individuals with Down syndrome to evaluate the safety and efficacy of anti-amyloid drugs and other potential AD therapies. These trials are essential to determine whether the benefits of these drugs outweigh the risks in this high-risk population and to develop tailored treatment strategies.
