ENVISION: A phase 3b/4 randomized, double‐blind, placebo‐controlled, parallel‐group study to verify the clinical benefit of aducanumab in participants with early Alzheimer’s disease

Aducanumab is a human monoclonal antibody selective for aggregated forms of amyloid beta approved in the United States by the Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease on June 7, 2021 under the accelerated approval pathway, which requires a randomized‐controlled trial with an appropriate control to verify the clinical benefit of aducanumab. On March 25, 2022 the sponsor submitted the final protocol for this trial, named ENVISION, to the FDA.