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
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
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.
Key Inclusion Criteria:
The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET
Must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
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 meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments
Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers)
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Los Angeles, California 90095, United States
Chicago, Illinois 60637, United States
Elk Grove Village, Illinois 60007, United States
Wichita, Kansas 67214, United States
Staten Island, New York 10314, United States
São Paulo, São Paulo 05403-010, Brazil
Bonn, North Rhine-Westphalia 53127, Germany
Arzignano VI, Vicenza 36071, Italy
Brescia, 25123, Italy
Naples, 80138, Italy
Roma, 00185, Italy
Obu-shi, Aichi-ken 474-8511, Japan
Koriyama-shi, Fukushima 963-8563, Japan
Otake-shi, Hiroshima 739-0696, Japan
Himeji-shi, Hyōgo 672-8043, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Atsugi-shi, Kanagawa 243-8551, Japan
Kamakura-shi, Kanagawa 247-8533, Japan
Kawasaki-shi, Kanagawa 213-8507, Japan
Kurashiki-shi, Okayama-ken 710-0813, Japan
Kishiwada-shi, Osaka 596-0042, Japan
Suita-shi, Osaka 565-0871, Japan
Kasukabe-shi, Saitama 344-0036, Japan
Kodaira-shi, Tokyo-To 187-8551, Japan
Guadalara, Jalisco 44610, Mexico
Lublin, 20-090, Poland