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
Gunzburg, Baden-Wurttemberg 89312, Germany
Bielefeld, North Rhine-Westphalia 33647, Germany
Siegen, North Rhine-Westphalia 57076, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Obu-shi, Aichi-ken 474-8511, Japan
Toon-shi, Ehime 791-0295, Japan
Kurume-shi, Fukuoka 830-0011, Japan
Otake-shi, Hiroshima 739-0696, Japan
Amagasaki-shi, Hyōgo 660-8511, Japan
Himeji-shi, Hyōgo 670-0981, Japan
Himeji-shi, Hyōgo 672-8043, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Nishisonogi, Nagasaki 851-2103, Japan
Yufu-shi, Oita Prefecture 879-5593, Japan
Kurashiki-shi, Okayama-ken 710-0813, Japan
Tsukuba-gun, Okayama-ken 701-0304, Japan
Kishiwada-shi, Osaka 596-8522, Japan
Sennan-shi, Osaka 590-0503, Japan
Suita-shi, Osaka 565-0871, Japan
Iwata-shi, Shizuoka 438-0043, Japan