Study Shows Promising Results for Potential Alzheimer’s Treatment

FDA approval could come this year

The drug’s manufacturer, Eli Lilly, said it is seeking full, traditional approval for donanemab from the U.S. Food and Drug Administration, with a decision expected by the end of the year.

Until recently, the only Alzheimer’s drugs with full FDA approval were medications that help to alleviate some of the disease’s symptoms, not disrupt its course. On July 6, however, the FDA issued its first full approval for a similar amyloid-clearing treatment, called Leqembi (lecanemab), which in studies was able to slow the rate of Alzheimer’s disease progression in individuals in the early to mild disease stages. Another anti-amyloid therapy called Aduhelm (aducanumab) received what’s known as accelerated approval from the FDA in 2021 but has not received traditional approval.

Like Leqembi, donanemab is a monoclonal antibody given by infusion. Side effects reported in the donanemab trial were similar to those seen with Leqembi, with swelling and bleeding in the brain being the chief concerns. Often these events are small, temporary and asymptomatic, but larger bleeds can occur and can be serious, even fatal.

Even as the FDA decides whether to approve this latest medication, the search for effective Alzheimer’s treatments continues. Howard Fillit, M.D., cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in a statement that the latest amyloid-attacking drugs are “just a start,” and that “we must continue advancing the drug pipeline to develop the next class of drugs centered around the biology of aging to ultimately stop Alzheimer’s in its tracks.” 

Hundreds of potential treatments are being studied, and many have targets other than amyloid.

“Alzheimer’s disease and related dementias are complex disorders, caused by a constellation of overlapping and intertwined chains of biochemical reactions that wreck the brain,” Richard J. Hodes, M.D., director of the National Institute on Aging, said in a statement. “Successfully treating each individual’s dementia will likely require a diverse set of preventative and diagnostic therapies. The data reported in these donanemab and lecanemab studies suggest that anti-amyloid therapies may, at least, be the first of many other treatments.”