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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 is a Phase 1 study of Alzheimers Disease that has completed, run by Biogen. The registered enrollment target is 53 participants, below the 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states.

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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.

Conditions Studied

Alzheimers Disease

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

334 total trials

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What the Registry Record Tells You About NCT01397539

The ClinicalTrials.gov registry entry for NCT01397539 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (99% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.