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Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.

NCT00575055•JANSSEN Alzheimer Immunotherapy Research & Development, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 88 years

Sex

ALL

Healthy Volunteers

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

Locations (186)

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

Key Dates

Start Date

December 1, 2007

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

November 25, 2013

Enrollment

1,121

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Bapineuzumab 0.5 mg/kg

DRUG

Placebo Control

DRUG

Bapineuzumab 1.0 m/kg

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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