Experimental Alzheimer’s Drug Slows Cognitive Declines in Large Trial, Drugmaker Eli Lilly Says

An experimental Alzheimer’s medication slowed declines in patients’ ability to think clearly and perform daily tasks by more than a third in a large clinical trial, drugmaker Eli Lilly said Wednesday. Based on the results, in people with early symptomatic Alzheimer’s disease, Lilly said it plans to file for approval from the US Food and Drug Administration by the end of June. The medicine, donanemab, works by removing plaque buildups in the brain known as amyloid that are a hallmark of Alzheimer’s disease. However, there were some side effects reported; there were three deaths in the trial among people taking the drug, two of which were attributed to adverse events such as brain swelling or microhemorrhages, known as amyloid-related imaging abnormalities or ARIA. The trial was run in more than 1,700 patients for 18 months.

“For every medicine, for every disease, there are potential risks and potential benefits,” said Lilly’s chief scientific and medical officer, Dr. Daniel Skovronsky. But he noted that almost half of the participants taking the drug, 47%, showed no decline on a key measure of cognition over the course of a year, compared with 29% of people taking a placebo. That’s “the kind of efficacy that’s never been seen before in Alzheimer’s disease,” Skovronsky said. Alzheimer’s affects more than 6 million Americans, with an estimated 1.7 million to 2 million people over 65 in the early stages of the disease, according to Lilly. Drug development for Alzheimer’s has been riddled with failures, but Lilly’s drug is among a new group showing promise. The first, Eisai and Biogen’s Leqembi, received accelerated FDA approval in January.