221AD301 早期アルツハイマー病患者を対象としたアデュカヌマブ（BIIB037）の第3相臨床試験

基本情報

NCT ID

NCT02477800

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,653

治験依頼者名

Biogen

概要

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) \[ADCS-ADL-MCI\].

対象疾患

介入

依頼者（Sponsor）