Large-scale trials for a new Alzheimer’s drug are enrolling patients across North America and abroad.
Backed by the National Institutes of Health and the American arm of Japanese pharmaceutical giant Eisai, the AHEAD Study administered its first dose of the drug in 2020 and will eventually involve more than 1,000 patients at 75 locations across the U.S. and Canada, plus approximately 25 more in Europe and East Asia.
The treatment, called BAN2401 and also known as lecanemab, is an intravenous drug developed by Eisai and Massachusetts-based Biogen. Biogen is also known for developing Aduhelm, a recently approved and controversial Alzheimer’s treatment.
According to Alzheimer’s News Today, lecanemab is an antibody that binds to the protein that makes up beta-amyloid plaque found in the brains of Alzheimer’s patients. In theory, the drug fights Alzheimer’s by “tagging” these proteins and making the immune system attack and remove them.
Lecanemab is not approved by the U.S. Food and Drug Administration, but it’s being developed under the FDA’s accelerated approval pathway, a process that allows for a faster approval process for novel drugs that could have a large impact on patients. The FDA approved Aduhelm under that pathway last year. The AHEAD Study is a phase 3 study, which means more research would be necessary before the drug is approved.
The four-year study is looking to enroll a wide range of participants worldwide, but participants must be 55-80 and not currently have Alzheimer’s disease or any other kind of dementia. A separate study is underway to test the drug’s effectiveness in patients who already have some cognitive impairment from the disease.
“We know that changes in the brains of people with Alzheimer’s disease begin up to 20 years before a person notices symptoms,” said Reisa Sperling, MD, the study’s co-principal investigator, in a press release, “but until now most clinical trials have included older patients who already have symptoms.”
Participants in the AHEAD Study are also required to undergo a number of regular examinations, including occasional MRI and PET scans to visualize the drug’s effect on the brain.
Anyone interested in participating in the AHEAD Study can find a location and enroll on the study’s website. Locations can be found in 30 states plus the District of Columbia, as well as the Canadian provinces of Ontario and Nova Scotia.