Clinical trial
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease (ENVISION)
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease (ENVISION)
ClinicalTrials.gov ID: NCT05310071
Sponsor: Biogen
Information provided by: Biogen (Responsible Party)
Last Update Posted: 2023-11-18
Brief Summary:
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.
Official Title:
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
Intervention / Treatment:
- Drug: Aducanumab
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-06-02 |
| Primary Completion (Estimated) | 2025-12-27 |
| Study Completion (Estimated) | 2026-10-31 |
| Enrollment (Estimated) | 1512 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
221AD305
|