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

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00575055

Run by

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

People needed

1121

Starts

2007-12-01

Expected to finish

2012-04-01

Last updated by the study team

2013-11-25

Who can join

Age: 50 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• ATP Clinical Research, Inc — Costa Mesa, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Margolin Brain Institute — Fresno, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Coordinated Clinical Research — La Jolla, California, United States
• University of California San Diego — La Jolla, California, United States
• Senior Clinical Trials, Inc — Laguna Hills, California, United States
• Collaborative NeuroScience Network, Inc. — Long Beach, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Vintage Institute for Clinical Research, Inc — Los Angeles, California, United States
• UCLA Department of Neurology — Los Angeles, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Neurology Center — Oceanside, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Neuro-Therapeutics Inc. — Pasadena, California, United States
• University of Alabama Hospital (UAB) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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