Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
- Conditions
- Alzheimer's Disease
- Interventions
- Registration Number
- NCT00575055
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1121
- 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
- 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)
Research Center for Clinical Studies, Inc
🇺🇸Norwalk, Connecticut, United States
The Roskamp Institute, Inc
🇺🇸Sarasota, Florida, United States
Jefferson Hospital for Neuroscience
🇺🇸Philadelphia, Pennsylvania, United States
Vintage Institute for Clinical Research, Inc
🇺🇸Los Angeles, California, United States
UCLA Department of Neurology
🇺🇸Los Angeles, California, United States
Multiple Sclerosis Center of Atlanta
🇺🇸Atlanta, Georgia, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Virginia
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Pharmax Research Clinic, LLC
🇺🇸Miami, Florida, United States
NeuroTrials Research, Inc.
🇺🇸Atlanta, Georgia, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Sutter Neuroscience Medical Group
🇺🇸Sacramento, California, United States
University of South Florida Suncoast Alzheimer's and Gerontology Center
🇺🇸Tampa, Florida, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
University of California Davis Alzheimer's Disease Research Center
🇺🇸Sacramento, California, United States
Neurology Associates
🇺🇸Maitland, Florida, United States
Medical Research and Health Educational Foundation, Inc
🇺🇸Columbus, Georgia, United States
Associated Neurologists of Southern CT, P.C.
🇺🇸Fairfield, Connecticut, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
Associated Neurologists, PC
🇺🇸Danbury, Connecticut, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Springfield Neurology Associates
🇺🇸Springfield, Massachusetts, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
DeKalb Neurology Associates, LLC
🇺🇸Decatur, Georgia, United States
Maine Medical Partners Neurology
🇺🇸Scarborough, Maine, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Emory University, School of Medicine
🇺🇸Atlanta, Georgia, United States
J. Gary Booker, MD, APMC
🇺🇸Shreveport, Louisiana, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
🇺🇸Tampa, Florida, United States
Southern Illinois University, School of Medicine
🇺🇸Springfield, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Elkhart Clinic, LLC
🇺🇸Elkhart, Indiana, United States
Saint Luke's Hospital, Mid America Brain and Stroke Institute
🇺🇸Kansas City, Missouri, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
ActivMed Practices and Research, Inc
🇺🇸Haverhill, Massachusetts, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
University of California at San Francisco Medical Center at Parnassus
🇺🇸San Francisco, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
University of Utah, Dept. of Neurology
🇺🇸Salt Lake City, Utah, United States
University of Alabama Hospital (UAB)
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Stratford, New Jersey, United States
Dedicated Clinical Research, Inc.
🇺🇸Goodyear, Arizona, United States
Banner Research Institute
🇺🇸Sun City, Arizona, United States
University of Arizona College of Medicine, Health Sciences Center
🇺🇸Tucson, Arizona, United States
Clinical Trials Inc.
🇺🇸Little Rock, Arkansas, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Coordinated Clinical Research
🇺🇸La Jolla, California, United States
Northwest NeuroSpecialists, PLLC
🇺🇸Tucson, Arizona, United States
East Bay Physicians Medical Group
🇺🇸Berkeley, California, United States
ATP Clinical Research, Inc
🇺🇸Costa Mesa, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
AVI Clinical Research
🇺🇸Carson, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Senior Clinical Trials, Inc
🇺🇸Laguna Hills, California, United States
Neurology Center
🇺🇸Oceanside, California, United States
Collaborative NeuroScience Network, Inc.
🇺🇸Long Beach, California, United States
Neuro-Therapeutics Inc.
🇺🇸Pasadena, California, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
JEM Research, LLC
🇺🇸Atlantis, Florida, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Bradenton Research Center, Inc
🇺🇸Bradenton, Florida, United States
Quantum Laboratories, Inc.
🇺🇸Deerfield Beach, Florida, United States
Clinical Physiology Associates, Inc.
🇺🇸Fort Myers, Florida, United States
Emerald Coast Mood & Memory, PA.
🇺🇸Fort Walton Beach, Florida, United States
Mayo Clinic College of Medicine
🇺🇸Jacksonville, Florida, United States
Neurologic Consultants, P.A.
🇺🇸Fort Lauderdale, Florida, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Melbourne Internal Medicine Associates, MIMA
🇺🇸Melbourne, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Ft. Myers, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Allied Clinical Trials, Inc.
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Palm Beach Neurological Center/Advanced Research Consultants
🇺🇸Palm Beach Gardens, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Meridien Research
🇺🇸St. Petersburg, Florida, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Suncoast Neuroscience Associates, Inc.
🇺🇸St Petersburg, Florida, United States
Neurostudies, Inc
🇺🇸Port Charlotte, Florida, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Alexian Brothers Neurosciences Institute
🇺🇸Elk Grove Village, Illinois, United States
Mid America Neuroscience Institute
🇺🇸Lenexa, Kansas, United States
Associates in Neurology, PSC
🇺🇸Lexington, Kentucky, United States
Four Rivers Clinical Research, Inc
🇺🇸Paducah, Kentucky, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Neurocare, Inc
🇺🇸Newton, Massachusetts, United States
Donald S. Marks, MD, P.C.
🇺🇸Plymouth, Massachusetts, United States
Borgess Medical Center/Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
St. Louis University School of Medicine
🇺🇸St. Louis, Missouri, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Advanced Neurology Specialists
🇺🇸Great Falls, Montana, United States
Memory Enhancement Center of America, Inc.
🇺🇸Eatontown, New Jersey, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Alzheimer's Research Corporation (ARC)
🇺🇸Manchester, New Jersey, United States
The NeuroCognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Neurological Associates Albany PC
🇺🇸Albany, New York, United States
Neuroscience Research Center at Albany Medical Center
🇺🇸Albany, New York, United States
Five Towns Neuroscience Research
🇺🇸Cedarhurst, New York, United States
Advanced BioBehavioral Sciences
🇺🇸Elmsford, New York, United States
Neurological Care of CNY
🇺🇸Liverpool, New York, United States
Parker Jewish Institute for Health Care & Rehabilitation
🇺🇸New Hyde Park, New York, United States
Empire Neurology, PC
🇺🇸Latham, New York, United States
NYU School of Medicine/Psychiatry
🇺🇸New York, New York, United States
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Clinical Trials of America, Inc
🇺🇸Hickory, North Carolina, United States
Nathan S. Kline Institute for Psychiatric Research
🇺🇸Orangeburg, New York, United States
University of Rochester Medical Center @ Monroe Community Hospital
🇺🇸Rochester, New York, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
New Hope Clinical Research
🇺🇸Hickory, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
🇺🇸Beachwood, Ohio, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
NeuroCare Center, Inc
🇺🇸Canton, Ohio, United States
Neurology Specialists, Inc.
🇺🇸Dayton, Ohio, United States
Red River Medical Research Center, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Summit Research Group, LLC
🇺🇸Portland, Oregon, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Providence Health Service System, AD Center, Brain Institute
🇺🇸Portland, Oregon, United States
Providence Medical Group-Medford Neurology
🇺🇸Medford, Oregon, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Abington Neurological Assoc
🇺🇸Abington, Pennsylvania, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Penn Memory Center
🇺🇸Philadelphia, Pennsylvania, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Universtiy of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Rhode Island Mood and Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Neurology Clinic, PC
🇺🇸Cordova, Tennessee, United States
Psychiatric Consultants, PC
🇺🇸Franklin, Tennessee, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
East Tennessee State University
🇺🇸Johnson City, Tennessee, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Integra Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
University of North Texas/Health Sciences Center-Fort Worth
🇺🇸Fort Worth, Texas, United States
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Alliance Research Group, LLC
🇺🇸Richmond, Virginia, United States
University of Washington Veterans Affairs
🇺🇸Seattle, Washington, United States
Innovative Clinical Research Center
🇺🇸Alexandria, Virginia, United States
Medical University of South Carolina
🇺🇸N. Charleston, South Carolina, United States
Pacific Medical Centers
🇺🇸Seattle, Washington, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Deaconess Billings Clinical Research Center
🇺🇸Billings, Montana, United States
Neuroscience Research of the Berkshires
🇺🇸Pittsfield, Massachusetts, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States