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NCT02484547 · ClinicalTrials.gov registry record · Phase 3
221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,643
- Enrollment target
NCT02484547 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 1,643 participants.
The verdict
NCT02484547, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,643 participants
- Enrollment target
Study 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) \[ADCS-ADL-MCI\].
Interventions
- DRUG Placebo
- DRUG Aducanumab (BIIB037)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,643 participants |
| Start Date | 2015-09-15 |
| Est. Completion | 2019-08-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02484547
The ClinicalTrials.gov registry entry for NCT02484547 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,643 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02484547 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02484547 about?
NCT02484547 is a clinical study titled "221AD302 Phase 3 Study of Aducanumab (BIIB037) in 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...
What is the current status of trial NCT02484547?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,643 participants. The study started on 2015-09-15. Estimated completion is 2019-08-05.
What interventions are being tested in trial NCT02484547?
The interventions under investigation include: Placebo (DRUG), Aducanumab (BIIB037) (DRUG).
Who is sponsoring clinical trial NCT02484547?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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