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NCT01397539 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
A Phase 1 study of Alzheimers Disease, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 3
- Study locations
NCT01397539: Completed Phase 1 study of Alzheimers Disease, sponsored by Biogen.
NCT01397539 is a Phase 1 study of Alzheimers Disease that has completed, run by Biogen. The registered enrollment target is 53 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397539, a Phase 1 study of Alzheimers Disease, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of BIIB037 after single-dose administration.
Primary Outcome
Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), and brain MRI findings (including the occurrence of vasogenic edema and incident hemorrhage).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG BIIB037
Study Locations (3)
Florida
- Brain Matters Research - Delray Beach
- Compass Research, LLC - Orlando
Ohio
- Insight Clinical Trials, LLC - Beachwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01397539 record still lists
NCT01397539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01397539 reports a single indexed study location in Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT01397539 about?
NCT01397539 is a clinical study titled "Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease". The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the ph...
What is the current status of trial NCT01397539?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2011-06. Estimated completion is 2013-08.
What conditions does trial NCT01397539 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01397539?
The interventions under investigation include: Placebo (OTHER), BIIB037 (DRUG).
Who is sponsoring clinical trial NCT01397539?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01397539 being conducted?
This trial has 3 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01397539's enrollment target sits among peer trials
53 94th of 147 higher than 53 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease 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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