The AHEAD Study is a clinical research study for people who may be at risk for memory problems. The purpose of the study is to see if the drug BAN2401 (lecanemab) can help reduce the risk of developing Alzheimer’s disease dementia. Amyloid build-up may lead to impairment in memory and thinking and is often found in people with Alzheimer’s disease. BAN2401 (lecanemab) is a human antibody that binds to amyloid proteins in the brain.
This drug is not FDA-approved and is investigational. Participants are randomly assigned to receive the investigational study drug or placebo (non-active agent used for comparison). The drug or placebo is given by an intravenous infusion. Based on imaging results, participants will be assigned to one of two arms of the study. One arm will receive the drug or placebo twice per month and the other arm will receive the drug or placebo once per month. This study is approximately four years in length.
Who can participate?
Healthy individuals 55-80 years of age who are cognitively normal. Participants must have a reliable study partner: a spouse, relative, or friend who knows the participant well and sees him or her often, who will attend some study visits, and who will provide information about the participant during the study.
What does the study include?
Screening, which may be spaced out over multiple visits, will determine eligibility. The screening includes:
- A physical and neurological exam
- Medical history and medication review
- Collection of blood and urine
- Assessments of your memory, thinking, mood and well-being
- Brain MRI and PET scans
After the screening, study activity includes:
- One “baseline” visit, then, depending on what arm of the study the participant is assigned to, 55 or 79 infusions spaced out over four years at the Clinical Translational Research Center at the Hospital of the University of Pennsylvania
- MRIs, memory and thinking tests, blood and urine collection, and assessments of mood and well-being
- An optional sub-study will include a lumbar puncture (LP) or “spinal tap”
Participants will be reimbursed for time and travel.
Before enrolling, the participant and study partner must read, understand, and sign a formal consent form which fully explains the study.Please visit www.aheadstudy.org to learn more about the study and find a location closest to you.