ENVISION: A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants with Alzheimer’s Disease
Sponsor: Biogen, MA, Inc.
Primary Investigator: Hamid Okhravi, MD
Summary: The ENVISION study is a Phase 3b/4 clinical trial 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, (including those with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia).
Aducanumab was approved by the FDA in June 2021 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. Consistent with the accelerated approval regulations, this study is being conducted to fulfill a post-marketing requirement from the FDA to verify the clinical benefit of aducanumab.
Qualifying study participants will be randomized in a 2:1 ratio to receive either aducanumab, up to 10 mg/kg or a placebo comparator. The total duration of this study for each participant will be approximately 130 weeks, including a series of screening visits within 8 weeks before administration of the first dose, and a 104-week placebo-controlled treatment period. The investigational product (IP) will be administered monthly throughout the treatment period as an intravenous line (IV) infusion. Participants will additionally undergo a safety follow-up visit 18 weeks after the final dose of aducanumab.
Point of Contact: Brielle R. Schreiter, MS Clinical Research Coordinator & ACTC Site Liaison.
Additional Contact: GlennanCenterResearchTrials@evms.edu
Key Inclusion Criteria (partial list):
- Male or Female, age 60-85 (inclusive)
- The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET.
- The participant must have a history of confirmed subjective memory decline with gradual onset and slow progression over the 6 months before screening.
- The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time.
- Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers).
Key Exclusion Criteria (partial list):
- Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening.
- Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to screening.
- History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product.
- Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to screening unless documentation of receipt of placebo is available.
- Use of any investigational drug.
- Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab).
Additional inclusion/exclusion criteria to be determined prior to enrollment
Additional Information:
