A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease (ENVISION)

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

Aducanumab is a human monoclonal antibody that is directed against the amyloid-β protein. Aducanumab was approved by the US FDA as a treatment for Alzheimer’s disease under the accelerated approval pathway based on aducanumab’s reduction in brain amyloid coupled with evidence that reduction in brain amyloid is reasonably likely to predict clinical benefit in Alzheimer’s disease. This is a Phase 3b/4, 2-year, placebo-controlled study designed to verify the clinical benefit of aducanumab compared to placebo in participants aged 60 to 85 with early Alzheimer’s disease.

Participants will be randomly assigned in a 2:1 ratio to receive up to 10 mg/kg of aducanumab or placebo administered intravenously every 4 weeks for up to 24 months (67% chance of receiving active study drug). All participants will undergo either a 18F-Florbetapir PET scan or a lumbar puncture to confirm the presence of cerebral Aβ accumulation, as well as 6 MRI scans. Participants will have the option of participating in amyloid (18F-Florbetapir) and/or tau (18F-MK6240) PET substudies, as well as a cerebrospinal fluid (CSF) lumbar puncture substudy. Permits concurrent treatment with cholinesterase inhibitors and memantine.

For more information please go to the Alzheimer's Disease Research Unit (ADRU) website for each of our studies: https://medicine.yale.edu/psychiatry/alzheimers/