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NCT00575055 · ClinicalTrials.gov registry record · Phase 3

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

A Phase 3 study, sponsored by JANSSEN Alzheimer Immunotherapy Research & Development.

Completed
Registry status
Phase 3
Development phase
1,121
Enrollment target

NCT00575055: Completed Phase 3 study, sponsored by JANSSEN Alzheimer Immunotherapy Research & Development.

NCT00575055 is a Phase 3 study that has completed, run by JANSSEN Alzheimer Immunotherapy Research & Development. The registered enrollment target is 1,121 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00575055, a Phase 3 study, has completed, sponsored by JANSSEN Alzheimer Immunotherapy Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
1,121 participants
Enrollment target

Study Summary

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Interventions

  • DRUG Placebo Control
  • DRUG Bapineuzumab 0.5 mg/kg
  • DRUG Bapineuzumab 1.0 m/kg

Trial Details

FieldValue
Enrollment Target 1,121 participants
Start Date 2007-12
Est. Completion 2012-04
Phase Phase 3

What the Registry Record Tells You About NCT00575055

The ClinicalTrials.gov registry entry for NCT00575055 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JANSSEN Alzheimer Immunotherapy Research & Development, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo Control is the first listed.

NCT00575055 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00575055 about?

NCT00575055 is a clinical study titled "Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)". This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either ...

What is the current status of trial NCT00575055?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,121 participants. The study started on 2007-12. Estimated completion is 2012-04.

What interventions are being tested in trial NCT00575055?

The interventions under investigation include: Placebo Control (DRUG), Bapineuzumab 0.5 mg/kg (DRUG), Bapineuzumab 1.0 m/kg (DRUG).

Who is sponsoring clinical trial NCT00575055?

This trial is sponsored by JANSSEN Alzheimer Immunotherapy Research & Development, which has 8 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.