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
Purpose of the Study
The primary purpose of this study is to investigate the safety and tolerability (whether side effects can be handled by a participant) of aducanumab (ADUHELM, also known as BIIB037) compared to a placebo (an infused drug that looks like the study drug but has no drug in it) for the treatment of Alzheimer’s Disease. The study will also assess the amount of the study drug that is infused. The study will also evaluate whether the study drug affects the symptoms of participants with Alzheimer’s Disease.
What to Expect
Over the course of study participation (2.5 years), you will:
- Be randomly assigned to a study group: Aducanumab (study drug) or placebo (saline solution, containing no active drug product). You do not get to pick your study group. You and your study doctor will not know if you are on the study drug or placebo.
- Come into the UCSF clinic for 39 study visits.
- Have an intravenous infusion of the study drug once a month for 104 weeks (2 years).
- Undergo brain scans (MRI), physical and neurological examinations, vital signs collection, blood and urine tests, lumbar puncture, and electrocardiograms (ECG).
- Complete questionnaires and undergo tests of your memory and daily functioning.
Please visit ClinicalTrials.gov for more information.