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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: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT02484547 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 1,643 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
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) \[ADCS-ADL-MCI\].
Primary Outcome
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal car
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 |
Why NCT02484547 stopped before completion
NCT02484547 is an interventional study that assigns participants to a tested intervention. Its 1,643 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (113% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02484547 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02484547's enrollment target sits among peer trials
1,643 141st of 2000 higher than 1,860 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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