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

Phase 3

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Bapineuzumab 0.5 mg/kg; Drug: Placebo Control; Drug: Bapineuzumab 1.0 m/kg

• Registration Number: NCT00575055
• Lead Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Disposition First Submitted: 2013-09-27
• Disposition First Submitted QC: 2013-09-27
• Status Verified: 2013-10
• Disposition First Posted: 2013-10-28
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1121

Inclusion Criteria

• Diagnosis of probable AD
• Age from 50 to less than 89
• Mini-Mental Status Exam score of 16-26 inclusive
• Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
• Stable doses of medications (cholinesterase inhibitors and memantine allowed)
• Caregiver able to attend all clinic visits with patient

Exclusion Criteria

• Significant neurological disease other than AD
• Major psychiatric disorder
• Significant systemic illness
• History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
• Smoking greater than 20 cigarettes per day
• Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
• Prior treatment experimental immunotherapeutics or vaccines for AD
• Women of childbearing potential
• Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bapineuzumab 0.5 mg/kg	Bapineuzumab 0.5 mg/kg	infusion every 13 weeks for a total of 6 infusions
Placebo Dose	Placebo Control	infusion every 13 weeks for a total of 6 infusions.
Bapineuzumab 1.0 m/kg	Bapineuzumab 1.0 m/kg	infusion every 13 weeks for a total of 6 infusions.

Primary Outcome Measures

Name	Time	Method
Cognitive and Functional	18 months

Secondary Outcome Measures

Name	Time	Method
Imaging and biochemical biomarkers of disease status	18 months
Cognitive and Global	18 months

Trial Locations

Locations (184)

University of Alabama Hospital (UAB); 🇺🇸 Birmingham, Alabama, United States

Dedicated Clinical Research, Inc.; 🇺🇸 Goodyear, Arizona, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

HOPE Research Institute, LLC; 🇺🇸 Phoenix, Arizona, United States

Banner Research Institute; 🇺🇸 Sun City, Arizona, United States

University of Arizona College of Medicine, Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Northwest NeuroSpecialists, PLLC; 🇺🇸 Tucson, Arizona, United States

Clinical Trials Inc.; 🇺🇸 Little Rock, Arkansas, United States

East Bay Physicians Medical Group; 🇺🇸 Berkeley, California, United States

AVI Clinical Research; 🇺🇸 Carson, California, United States

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