This clinical trial focuses on studying Preclinical Alzheimer’s Disease in people who have different levels of brain amyloid buildup. The study tests a medication called lecanemab (also known as BAN2401), which is given through intravenous infusion. During the study, some participants will also receive imaging tests using two special substances: [18F]NAV4694 and [18F]MK-6240, which help visualize changes in the brain.
The main purpose is to determine if lecanemab works better than placebo in people who are in the early stages of Alzheimer’s disease but have not yet developed symptoms. The study consists of two parts: one for people with high levels of amyloid in the brain (A45 Trial) and another for those with intermediate levels (A3 Trial). The treatment period lasts for 216 weeks, which is about four years.
During the study, participants will receive regular doses of either lecanemab or placebo through an IV line. They will also undergo brain imaging tests called PET scans that use special tracking substances to measure the amount of amyloid and another protein called tau in their brains. The study includes regular memory and thinking tests to track any changes in brain function over time. After the main study period, participants may have the option to continue in an extension phase of the trial.



Spain