Official Study Title: AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216-Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects with Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects with Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
Please be aware that this study is experiencing longer than usual wait times to be contacted for screening.
Purpose
The AHEAD 3-45 Study is testing whether lecanemab can lower people’s risk of memory loss due to Alzheimer’s disease. The primary purpose of the AHEAD 3-45 Study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by a PET scan (or Positron Emission Tomography brain scan) at 216 weeks of treatment (A3 Trial).
What to Expect
- The AHEAD Study is comprised of two different clinical trials testing lecanemab in people who may be at risk for memory problems. Study participants are enrolled in one of two AHEAD trials based on the level of amyloid in their brain, as measured by amyloid positron emission tomography.
- Participants with intermediate amyloid levels take part in the AHEAD A-3 trial an will receive lecanemab once every 4 weeks for 4 years.
- Participants with elevated amyloid levels take part in the AHEAD A-45 trial and will receive 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 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 to look at amyloid and tau (another protein) in their brain. This helps the participants and researchers track their health. The PET scan takes pictures of participants’ brains, allowing researchers to see and track changes in amyloid and tau levels.
Eligibility
Participants Eligible for the AHEAD Study are:
- Healthy adults ages 55-80.
- Have not been diagnosed with Alzheimer’s disease or another dementia.
- Have elevated or intermediate levels of amyloid in their brain, found by imaging as part of the study.
- Have a study partner, either a close relative or friend, who will participate in one study visit per year.
- For more details, please see the AHEAD study website.
UW ADRC Study Contact:
Coordinator: Evangeline Chang| evchang@uw.edu| 206-685-8630
UW ADRC Site PI:
Darla Chapman, Clinical Trials Coordinator and Clinician, ADRC
