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NCT01677572 · ClinicalTrials.gov registry record · Phase 1
Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease
A Phase 1 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 197
- Enrollment target
NCT01677572: Clinical Trial Phase 1 study, sponsored by Biogen.
NCT01677572 is a Phase 1 study that was terminated before completion, run by Biogen. The registered enrollment target is 197 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (228% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677572, a Phase 1 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 197 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of multiple doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose serum concentrations of Aducanumab and to evaluate the immunogenicity of Aducanumab after multiple dose administration in this population.
Interventions
- DRUG Placebo
- DRUG Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2012-10-05 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
Why NCT01677572 stopped before completion
NCT01677572 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (228% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01677572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01677572 about?
NCT01677572 is a clinical study titled "Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease". The primary objective of this study is to evaluate the safety and tolerability of multiple doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to assess the effect on cerebral amyl...
What is the current status of trial NCT01677572?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 197 participants. The study started on 2012-10-05. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT01677572?
The interventions under investigation include: Placebo (DRUG), Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) (DRUG).
Who is sponsoring clinical trial NCT01677572?
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 NCT01677572's enrollment target sits among peer trials
197 278th of 2000 higher than 1,722 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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