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The AHEAD Study
The AHEAD Study is testing whether an investigational treatment can lower people’s risk of memory loss due to Alzheimer’s disease.
Cutting Edge Research
Researchers have learned that changes in the brains of people with Alzheimer’s disease start as many as 20 years before they notice symptoms like memory problems.
During those two decades, a protein in the brain called “amyloid” builds up in people who go on to have memory problems because of Alzheimer’s disease. While not all people with amyloid in their brain will develop memory problems, we know that the people who do are at a higher risk for developing the disease.
What is the AHEAD Study?
The AHEAD Study is comprised of two different clinical trials testing the same investigational drug (known as BAN2401 (lecanemab)) in people who may be at risk for memory problems. Participants will receive personalized study treatment, instead of a one-size-fits-all approach. Study participants are enrolled in one of two AHEAD trials based on the level of amyloid in their brain:
- Participants with intermediate amyloid levels take part in the AHEAD A-3 trial—the first ever trial aimed at what may be the earliest signs of Alzheimer’s disease. Participants in the AHEAD A-3 trial will receive BAN2401 (lecanemab) once every 4 weeks for 4 years.
- Participants with elevated amyloid levels take part in the AHEAD A-45 trial. Participants in the AHEAD A-45 trial will receive BAN2401 (lecanemab) once every 2 weeks for about 2 years and then once every 4 weeks for the remainder of the study.
Participants in both trials will receive intravenous (IV) infusions of BAN2401 (lecanemab), tailored to their risk of developing memory loss, or a placebo, an inactive substance designed to mimic the appearance of the drug. The infusion takes approximately 60 minutes.
At different points in the study, participants have a PET scan (or Positron Emission Tomography brain scan), to look at amyloid and tau (another protein) in their brain. This helps the participants and researchers track their health and this is the first study of its kind to use PET scans to measure amyloid and tau in all participants. The PET scan takes pictures of participants’ brains, allowing researchers to see and track changes in amyloid and tau levels.
To learn more, visit the eligibility requirements page.
The study is funded by the National Institutes of Health, in partnership with the pharmaceutical company Eisai. It is being conducted by the NIH-funded Alzheimer’s Clinical Trial Consortium (ACTC), a network of leading academic Alzheimer’s research centers.
The AHEAD Study has 100 study locations worldwide, including in North America, Japan, Singapore, Australia, and Europe—nearly 75 of which are in the United States and Canada. The study is led by Alzheimer’s disease research experts and academic leadership at the University of Southern California’s Alzheimer’s Therapeutic Research Institute, Brigham and Women’s Hospital, Massachusetts General Hospital, and Harvard Medical School.
The researchers leading the design and implementation of the study are:
Paul Aisen, M.D.
Director, Alzheimer’s Therapeutic Research Institute
Reisa Sperling, M.D.
Professor of Neurology, Harvard Medical School
Director, Center for Alzheimer Research and Treatment, Brigham and Women’s Hospital and Massachusetts General Hospital
Keith Johnson, M.D.
Professor of Radiology, Harvard Medical School
Director of Molecular Neuroimaging, Massachusetts General Hospital
Neurologist, Brigham and Women’s Hospital