Clinical trial participant ’s autopsy and brain exam stoke Alzheimer’s drug fears

A full autopsy and detailed examination of the brain of a 79-year-old Florida woman who died after receiving lecanemab, an experimental Alzheimer’s therapy, in a pivotal clinical trial has deepened some researchers’ concerns that it poses serious risks for patients who share the woman’s hard-to-diagnose, preexisting condition. The patient’s history and autopsy “strongly suggests that lecanemab infusions were a catalyst leading to the events resulting in her death,” says Vanderbilt University pathologist Hannah Harmsen, co-author of a recently completed case report, which Science has obtained. The authors say the woman’s fatal brain swelling and hemorrhaging likely resulted when the drug, a monoclonal antibody, attacked the abnormal protein deposits that had built up in her blood vessels. At the end of March, worries about such side effects led some prominent Alzheimer’s scientists to urge more stringent prescribing criteria for lecanemab than the Food and Drug Administration (FDA) signed off on in 2022 when giving it provisional approval based on biomarker evidence. But some authors of the new case report and others who have studied lecanemab’s side effects argue that the proposed “Appropriate Use Recommendations,” from researchers who all have current or recent ties to the antibody’s makers, still don’t go far enough to protect potential recipients. The case report and the experts’ recommendations are likely t...
Source: Science of Aging Knowledge Environment - Category: Geriatrics Source Type: research