As some hail new antibody treatment for Alzheimer ’s, safety and benefit questions persist

In a packed San Francisco conference room with a celebratory atmosphere, upbeat company representatives and scientists yesterday presented detailed clinical trial data on the first Alzheimer’s treatment shown to clearly, albeit modestly, slow the disease’s normal cognitive decline. The antibody therapy has buoyed a field marked by decades of failures. Now, it appears to be on the cusp of being greenlit by the U.S. Food and Drug Administration (FDA). Yet other researchers warn of potential risks, including brain swelling and brain hemorrhages that were linked to the recently disclosed deaths of two trial participants who received the antibody. Officials from the lead company sponsor, Eisai Co., confirmed the two deaths yesterday, but denied that they resulted from its experimental therapy. The Japanese company has been developing the monoclonal antibody lecanemab to remove a protein called amyloid-beta in early-stage Alzheimer’s. The protein clusters in the brains of people with the disease and is widely thought to cause its neurodegeneration. Other antibodies and strategies have chased amyloid’s removal, but lecanemab is the first to do so and clearly delay the onset of dementia symptoms. Many scientists and advocates are hailing these results as the strongest validation yet of the amyloid hypothesis of Alzheimer’s. The new data “confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s...
Source: Science of Aging Knowledge Environment - Category: Geriatrics Source Type: research