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COMPLETED Phase 1

Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease

NCT01397539 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 53 participants
Start Date 2011-06
Est. Completion 2013-08
Phase Phase 1

Sponsor

Biogen

74 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01397539

The ClinicalTrials.gov registry entry for NCT01397539 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01397539 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Alzheimer's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01397539?

The interventions under investigation include: Placebo (OTHER), BIIB037 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01397539?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial