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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 is a Phase 1 study that was terminated before completion, run by Biogen. The registered enrollment target is 197 participants.

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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

FieldValue
Enrollment Target 197 participants
Start Date 2012-10-05
Est. Completion 2019-07-31
Phase Phase 1

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT01677572

The ClinicalTrials.gov registry entry for NCT01677572 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01677572 reports 0 study locations.

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.

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.