MedTrace Logo

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

NCT00574132 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1331

Last updated 2013-11-25

No results posted yet for this 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 230 study sites in the US and Canada and up to 35 sites outside of North America 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.

Conditions

Interventions

DRUG

Bapineuzumab 0.5 mg/kg

infusion every 13 weeks for a total of 6 infusions

DRUG

Placebo Control

given by infusion every 13 weeks for a total of 6 infusions.

DRUG

Bapineuzumab 1.0 m/kg

infusion every 13 weeks for a total of 6 infusions

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • JANSSEN Alzheimer Immunotherapy Research & Development, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States
  • Austria
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00574132 on ClinicalTrials.gov