Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02484547
Status:
TERMINATED
Last Update Posted:
2021-09-02
First Post:
2015-06-18
Brief Title:
221AD302 Phase 3 Study of Aducanumab BIIB037 in Early Alzheimers Disease
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
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 Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was discontinued based on futility analysis done and not based on safety concerns Follow-up visits and closing out study activities are completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMERGE
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-000967-15 | EUDRACT_NUMBER | None | None |