AHEAD

Recruitments for the AHEAD Study have been successfully concluded. We would like to extend our heartfelt thanks to all the participants, researchers, and support staff who contributed to this significant milestone. Your dedication and cooperation have been invaluable in advancing our understanding and objectives. Stay tuned for updates on our findings and future opportunities to engage with our research initiatives.

About AHEAD:

Researchers have learned that changes in the brains of people with Alzheimer’s disease begin up to 20 years before a person notices any symptoms. During those two decades, a protein in the brain called amyloid builds up in people who may go on to have memory and thinking problems because of Alzheimer’s disease. While not all people with amyloid in their brain will develop memory problems, we know that people with amyloid in their brain are at higher risk for developing cognitive decline.

Funded by the National Institutes of Health and Eisai, Inc. the AHEAD study tests whether an investigational treatment aimed at removing amyloid from the brain can also slow the earliest memory change in people with a higher risk of developing Alzheimer’s disease.

The AHEAD Study tests whether intervening ahead of symptoms may prevent future memory loss and dementia. The study looks at an investigational treatment aimed at delaying memory decline in people up to 20 years before the symptoms of Alzheimer’s disease appear. The AHEAD Study is made up of two different research trials testing the same investigational treatment (known as BAN2401 or lecanemab). Participants will receive a specific treatment approach, depending on which trial they qualify for, instead of a one-size-fits-all approach.

The two AHEAD trials enroll participants with different levels of amyloid in the brain:

Participants with intermediate amyloid levels take part in the AHEAD A-3 trial—the first study aimed at investigating this very early stage of brain change. Participants in the A-3 trial receive a lower dose of BAN2401 (lecanemab).
Participants with elevated amyloid levels take part in the AHEAD A-45 preclinical Alzheimer’s disease trial and will receive a higher dose of BAN2401 (lecanemab), which has been shown to lower brain amyloid levels in people with Alzheimer’s dementia.

To determine eligibility for the AHEAD Study, potential participants must have a PET (or Positron Emission Tomography brain) scan to measure the level of amyloid in the brain. This exam will reveal whether a participant has elevated, intermediate, or not detectable levels of amyloid.

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.

Amyloid PET imaging scans from a representative participant in the Phase 2 trial of BAN2401 (lecanemab) – the investigational treatment being tested in the AHEAD 3-45 Study. Amyloid PET scans measure the levels of amyloid plaque in the brain. The image on the left is taken before the participant has started on the investigational treatment. The image on the right is taken after 18 months of investigational treatment with BAN2401 (lecanemab), indicating a reduction of amyloid plaque burden in the brain. (Data presented at AAIC 2019)