A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Kansas City, Kansas 66160, United States
Wichita, Kansas 67214, United States
Torrette Di Ancona, Ancona 60126, Italy
Inzai-shi, Chiba, Japan
Kurume-shi, Fukuoka 830-0011, Japan
Aizuwakamatsu-shi, Fukushima 965-8585, Japan
Asahikawa-shi, Hokkaido 070-8644, Japan
Atsugi-shi, Kanagawa 243-8551, Japan
Kamakura-shi, Kanagawa 247-8533, Japan
Kawasaki-Shi, Kanagawa 211-8533, Japan
Nagaoka-shi, Niigata 940-2081, Japan
Iruma-gun, Saitama 350-0495, Japan
Kasukabe-shi, Saitama 344-0036, Japan
Shinjuku-ku (I), Tokyo-To 162-8655, Japan
Shinjuku-ku, Tokyo-To 162-8655, Japan
Itabashi-ku, 173-0015, Japan
Itabashi-ku, 173-8610, Japan
Kiyose-shi, Japan
Kodaira-shi, 187-8551, Japan
Incheon, Gyeonggi-do 22332, South Korea
Taoyuan County, 333, Taiwan
London, Greater London WC1N 3BG, United Kingdom