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NCT05310071 · ClinicalTrials.gov registry record · Phase 3
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,027
- Enrollment target
NCT05310071: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT05310071 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 1,027 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05310071, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,027 participants
- Enrollment target
Study Summary
The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.
Primary Outcome
The Clinical Dementia Rate Scale integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following the caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provide
Interventions
- DRUG Placebo
- DRUG Aducanumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,027 participants |
| Start Date | 2022-06-02 |
| Est. Completion | 2024-08-12 |
| Phase | Phase 3 |
Why NCT05310071 stopped before completion
NCT05310071 is an interventional study that assigns participants to a tested intervention. Its 1,027 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 (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05310071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05310071 about?
NCT05310071 is a clinical study titled "A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease". The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's...
What is the current status of trial NCT05310071?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,027 participants. The study started on 2022-06-02. Estimated completion is 2024-08-12.
What interventions are being tested in trial NCT05310071?
The interventions under investigation include: Placebo (DRUG), Aducanumab (DRUG).
Who is sponsoring clinical trial NCT05310071?
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 NCT05310071's enrollment target sits among peer trials
1,027 288th of 2000 higher than 1,713 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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