216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 (lecanemab) 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)
HEALTHY PARTICIPANTS: Yes
The purpose of this study is to test whether an investigational drug, BAN2401 (lecanemab) can help reduce the risk of developing AD dementia. The data that we collect during the screening process of the study, as well as the information we collect from the two trials, will be shared broadly with researchers outside of this study, so that other researchers are learning from people enrolled in this research study. Information that can identify you will not be included with any shared research data.
The AHEAD Study is comprised of two different clinical trials testing BAN2401 (lecanemab) in people who may be at risk for memory problems. The two trials are very similar overall.
AHEAD-3 Trial will included participants with intermediate levels of amyloid in the brain and receive intravenous (into the vein, or IV) infusions of BAN2401 (lecanemab) or placebo (an inactive substance) every 4 weeks for about 4 years, for a total of 55 infusions.
AHEAD-45 Trial will include participants with elevated amyloid in the brain and receive IV infusions of BAN2401 (lecanemab) or placebo every 2 weeks for the first 2 years, and then every 4 weeks for the last 2 years, for a total of 79 infusions.
Who Can Participate
Participants between 55-80 years of age who have not been diagnosed with Alzheimer’s disease or another dementia but may be at risk for memory problems may be eligible for this study.