Phase 3 Trial of Lecanemab Seeks People at Risk of Alzheimer’s

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by Vanda Pinto PhD |

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The University of Wisconsin School of Medicine and Public Health is recruiting participants for a Phase 3 trial that will test the efficacy and safety of lecanemab (BAN2401) in those who are at risk of developing symptoms of Alzheimer’s disease.

The global AHEAD (NCT04468659) study seeks to enroll 1,165 participants in North America to test lecanemab in a larger group of people, after encouraging data in previous Phase 1 and 2 trials.

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Developed by Eisai and Biogen, lecanemab is an antibody designed to bind to a soluble, damaging version of the amyloid-beta protein that clumps into toxic plaques in the brain, contributing to Alzheimer’s. By binding to this form of amyloid-beta, the antibody is expected to “tag” it as harmful, promoting its clearance by the immune system before it clumps and forms toxic plaques. As such, it could potentially slow Alzheimer’s progression.

The AHEAD trial is the first of its kind to recruit people as young as 55 years who are at risk of developing Alzheimer’s as they age. Risk factors for the disease include family history of the condition or being 65 or older. The study will also test lecanemab in patients from diverse communities that are typically underrepresented in clinical studies, specifically communities of color, which are known to have a higher incidence of Alzheimer’s.

Study participants must be cognitively healthy. Those interested and who meet eligibility requirements can also contact the lead study coordinator at UW-Madison, at 608-263-4646 or by email.

“We know that changes in the brains of people with Alzheimer’s disease begin up to 20 years before a person notices symptoms, but until now, most clinical trials have included older patients who already have symptoms,” Cynthia Carlsson, MD, the principal investigator of the study location at UW-Madison, said in a university press release.

“By inviting younger participants without symptoms, we hope to help individuals who are at higher risk — such as people with family history — get ahead of the disease with early intervention. We also want to reach diverse communities to learn more about why people of color may be at higher risk of cognitive decline,” Carlsson added.

The trial will tailor lecanemab dosing levels to a participant’s brain amyloid level. The study is divided into two different trials, named A3 and A45, each of which will include participants based on their brain levels of amyloid-beta.

People with moderate amounts of amyloid-beta will be enrolled in the A3 trial and those with elevated levels will be in the A45 trial. Participants will receive lecanemab (5 milligram per kilogram, mg/kg), or a placebo, given directly into the bloodstream every two or four weeks through eight weeks. Then, the dose increases to 10 mg/kg given every two or four weeks through approximately four years.

The primary goal of this study is to understand if lecanemab is superior to placebo in reducing brain amyloid accumulation (A3 trial) and evaluate its capacity to prevent cognitive decline (A45).

Screening visits, blood tests, cognitive testing, imaging scans, and physical exams will be conducted throughout the study during the four-year period.