Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
- Conditions
- Alzheimer's Disease
- Interventions
- Registration Number
- NCT00574132
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1331
- 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 Control 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 Cognitive and Global 18 months Imaging and biochemical biomarkers of disease status 18 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (247)
Neurostudies, Inc
🇺🇸Port Charlotte, Florida, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Meridien Research
🇺🇸St. Petersburg, Florida, United States
Jefferson Hospital for Neuroscience
🇺🇸Philadelphia, Pennsylvania, United States
MS Center of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Claghorn-Lesem Research Clinic, Ltd.
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Washington Veterans Affairs
🇺🇸Seattle, Washington, United States
Pacific Medical Centers
🇺🇸Seattle, Washington, United States
Pharmax Research Clinic, LLC
🇺🇸Miami, Florida, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Allied Clinical Trials, Inc.
🇺🇸Miami, Florida, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Integra Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
Universitätsklinikum des Saarlandes
🇩🇪Homburg/Saar, Saarland, Germany
Mid America Neuroscience Institute
🇺🇸Lenexa, Kansas, United States
Kansas Multi-Specialist Group
🇺🇸Kansas City, Kansas, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
The Neurology Center
🇺🇸Oceanside, California, United States
NeuroTrials Research, Inc.
🇺🇸Atlanta, Georgia, United States
Dekalb Neurology Associates
🇺🇸Decatur, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Southern Illinois University, School of Medicine
🇺🇸Springfield, Illinois, United States
Elkhart Clinic, LLC
🇺🇸Elkhart, Indiana, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
St. Louis University School of Medicine
🇺🇸St. Louis, Missouri, United States
Nathan S. Kline Institute for Psychiatric Research
🇺🇸Orangeburg, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Rakesh Ranjan, M.D. & Associates, Inc.
🇺🇸Beachwood, Ohio, United States
Neurology and Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Rhode Island Mood and Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
Grayline Clinical Drug Trials, Inc
🇺🇸Wichita Falls, Texas, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
ATP Clinical Research, Inc
🇺🇸Costa Mesa, California, United States
Senior Clinical Trials
🇺🇸Laguna Hills, California, United States
University of California San Diego/Shela Marcos Alzheimer's Disease Research Center
🇺🇸La Jolla, California, United States
UCLA Department of Neurology
🇺🇸Los Angeles, California, United States
Integrated Medical and Behavioral Associates
🇺🇸Glendale, California, United States
East Bay Physicians Medical Group
🇺🇸Berkeley, California, United States
Collaborative Neuroscience Network
🇺🇸Long Beach, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Sun Valley Behavioral Medical Center
🇺🇸Imperial, California, United States
Synergy Research
🇺🇸National City, California, United States
Diablo Clinical Research, Inc
🇺🇸Walnut Creek, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Associated Neurologists of Southern CT, P.C.
🇺🇸Fairfield, Connecticut, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Santa Ana, California, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Roskamp Institute
🇺🇸Sarasota, Florida, United States
Advanced Neurology Specialists
🇺🇸Great Falls, Montana, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Maine Medical Partners Neurology
🇺🇸Scarborough, Maine, United States
Donald S. Marks, MD, P.C.
🇺🇸Plymouth, Massachusetts, United States
Dartmouth Hitchcock Medical Center, Dept of Neurology
🇺🇸Lebanon, New Hampshire, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
University Memory and Aging Center University Hospitals of Cleveland/Case Medical Center
🇺🇸Cleveland, Ohio, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
University of British Columbia (UBC) Hospital
🇨🇦Vancouver, British Columbia, Canada
Universitätsklinik Tübingen
🇩🇪Tübingen, Baden-wuerttemberg, Germany
Mile High Research Center
🇺🇸Denver, Colorado, United States
University of Alabama Hospital (UAB)
🇺🇸Birmingham, Alabama, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Red River Medical Research Center, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburg, Pennsylvania, United States
Summit Research Group, Inc.
🇺🇸Portland, Oregon, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Northwest Neurospecialists, PLLC
🇺🇸Tucson, Arizona, United States
Bradenton Research Center, Inc
🇺🇸Bradenton, Florida, United States
Coordinated Clinical Research
🇺🇸La Jolla, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Vintage Institute for Clinical Research, Inc
🇺🇸Los Angeles, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
The Southwest Institute for Clinical Research, Inc.
🇺🇸Rancho Mirage, California, United States
Neuro-Therapeutics Inc.
🇺🇸Pasadena, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Brain Matters Research, Inc.
🇺🇸Delray Beach, Florida, United States
Neurologic Consultants, P.A.
🇺🇸Fort Lauderdale, Florida, United States
Mayo Clinic College of Medicine
🇺🇸Jacksonville, Florida, United States
Sunrise Clinical Research, Inc.
🇺🇸Hollywood, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Neurology Associates
🇺🇸Maitland, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Emory University/School of Medicine
🇺🇸Atlanta, Georgia, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Medical Research and Health Education Foundation, Inc.
🇺🇸Columbus, Georgia, United States
Alexian Brothers Neurosciences Institute
🇺🇸Elk Grove Village, Illinois, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins School of Medicine
🇺🇸Baltimore, Maryland, United States
CBH Health, LLC
🇺🇸Rockville, Maryland, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Neuroscience Research of the Berkshires
🇺🇸Pittsfield, Massachusetts, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
Memory Wellness Clinic
🇺🇸Springfield, Massachusetts, United States
ActivMed Practices and Research, Inc
🇺🇸Haverhill, Massachusetts, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
The NeuroCognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
Shore Neurology, P.A.
🇺🇸Toms River, New Jersey, United States
Neuroscience Research Center at Albany Medical Center
🇺🇸Albany, New York, United States
Neurological Associates of Albany, P.C.
🇺🇸Albany, New York, United States
Empire Neurology, PC
🇺🇸Latham, New York, United States
Five Towns Neuroscience Research
🇺🇸Cedarhurst, New York, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn, New York, United States
Advanced Bio-Behavioral Sciences
🇺🇸Elmsford, New York, United States
NYU School of Medicine/Psychiatry
🇺🇸New York, New York, United States
Columbia University/Medical Center
🇺🇸New York, New York, United States
Parker Jewish Institute for Health Care & Rehabilitation
🇺🇸New Hyde Park, New York, United States
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Dent Neurologic Institute
🇺🇸New York, New York, United States
Neurological Care of CNY
🇺🇸Liverpool, New York, United States
Clinical Trials of America, Inc
🇺🇸Hickory, North Carolina, United States
New Hope Clinical Research
🇺🇸Hickory, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
NeuroCare Center, Inc
🇺🇸Canton, Ohio, United States
Neurology Specialists, Inc.
🇺🇸Dayton, Ohio, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Abington Neurological Associates, Ltd
🇺🇸Abington, Pennsylvania, United States
Penn Memory Center
🇺🇸Philadelphia, Pennsylvania, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Psychiatric Consultants, PC
🇺🇸Franklin, Tennessee, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
University of North Texas/Health Sciences Center-Fort Worth
🇺🇸Fort Worth, Texas, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Innovative Clinical Research Center
🇺🇸Alexandria, Virginia, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
University of Utah, Dept of Neurology
🇺🇸Salt Lake City, Utah, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Medical Arts Health Research Group
🇨🇦Penticton, British Columbia, Canada
Neurology Research Inch./Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Toronto Centre for Memory and Aging
🇨🇦Toronto, Ontario, Canada
Ontario Shores Centre for Mental Health Scienes
🇨🇦Whitby, Ontario, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Douglas Mental Health University Institute
🇨🇦Verdun, Quebec, Canada
Universitätsklinik Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
Universitätsklinik Ulm
🇩🇪Ulm, Baden-wuerttemberg, Germany
Klinikum Rechts der Isar der Technischen Universität München
🇩🇪München, Bayern, Germany
UKE Hamburg
🇩🇪Hamburg, Germany
Sutter Neuroscience Medical Group
🇺🇸Sacramento, California, United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
🇺🇸New Haven, Connecticut, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
University of California, Davis, Alzheimer's Disease Center
🇺🇸Sacramento, California, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
University of South Florida Suncoast Alzheimer's and Gerontology Center
🇺🇸Tampa, Florida, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Associated Neurologists, PC
🇺🇸Danbury, Connecticut, United States
Research Center for Clinical Studies, Inc
🇺🇸Norwalk, Connecticut, United States
University of Arizona College of Medicine, Health Science Center
🇺🇸Tucson, Arizona, United States
Springfield Neurology Associates
🇺🇸Springfield, Massachusetts, United States
Dedicated Clinical Research, Inc.
🇺🇸Goodyear, Arizona, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Palm Beach Neurological Center/Advanced Research Consultants
🇺🇸Palm Beach Gardens, Florida, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Louisana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Borgess Medical Center/Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Ft. Myers, Florida, United States
Banner Research Institute
🇺🇸Sun City, Arizona, United States
Suncoast Neuroscience Associates, Inc.
🇺🇸St Petersburg, Florida, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Stratford, New Jersey, United States
Alzheimer's Research Corporation (ARC)
🇺🇸Manchester, New Jersey, United States
Independent Pyschiatric Consultants
🇺🇸Waukesha, Wisconsin, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Clinical Physiology Associates, Inc.
🇺🇸Fort Myers, Florida, United States
Clinical Trials Inc.
🇺🇸Little Rock, Arkansas, United States
Medizinische Universität Graz
🇦🇹Graz, Styria, Austria
Medizinische Universität Wien
🇦🇹Wien, Vienna, Austria
Medical University of South Carolina
🇺🇸N. Charleston, South Carolina, United States
Quantum Laboratories, Inc.
🇺🇸Deerfield Beach, Florida, United States
Ludwig-Maximilians-Universität München
🇩🇪München, Bayern, Germany
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft GmbH
🇩🇪Dresden, Saschen, Germany
Broward Research Group, Inc.
🇺🇸Pembroke Pines, Florida, United States
University of Calgary, Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Hotel Dieu Hospital/Queens University Memorial Clinics
🇨🇦Kingston, Ontario, Canada
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Melbourne International Medicine Associates, MIMA
🇺🇸Melbourne, Florida, United States
Bruyere Continuing Care
🇨🇦Ottawa, Ontario, Canada
Saint Josefs Hospital
🇩🇪Bochum, Nordrhein-westfalen, Germany
J. Gary Booker, MD, APMC
🇺🇸Shreveport, Louisiana, United States
Deaconess Billings Clinical Research Center
🇺🇸Billings, Montana, United States
Emerald Coast Mood & Memory, PA.
🇺🇸Fort Walton Beach, Florida, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Coastal Neurology, PA
🇺🇸Dover, New Hampshire, United States
East Tennessee State University
🇺🇸Johnson City, Tennessee, United States
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Neuro Rive-Sud Memory Clinic
🇨🇦Greenfield Park, Quebec, Canada
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Universitätsklinikum Regensburg
🇩🇪Regensburg, Byern, Germany
Providence Medical Group-Medford Neurology
🇺🇸Medford, Oregon, United States
Parkwood Hospital
🇨🇦London, Ontario, Canada
Coastal Research Associates, Inc.
🇺🇸Weymouth, Massachusetts, United States
The Memory Enhancement Center of America, Inc.
🇺🇸Eatontown, New Jersey, United States
Providence Health Service System, AD Center, Brain Institute
🇺🇸Portland, Oregon, United States
Neurology Clinic, PC
🇺🇸Cordova, Tennessee, United States
Hopital Maisonneuve-Rosemont, Comite d' ethique de la recherche
🇨🇦Montreal, Quebec, Canada
Universitätsklinikum Ulm
🇩🇪Günzburg, Bayern, Germany
AFL Arzneimittelforschung Leipzig GmbH
🇩🇪Leipzig, Sachen, Germany
Saint Joseph's Health Care London, Saint Joseph's Hospital
🇨🇦London, Ontario, Canada
Kawartha Regional Memory Clinic
🇨🇦Peterborough, Ontario, Canada
Associates in Neurology, PSC
🇺🇸Lexington, Kentucky, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Louisiana Research Associates, Inc.
🇺🇸New Orleans, Louisiana, United States
Saint Luke's Hospital, Mid America Brain and Stroke Institute
🇺🇸Kansas City, Missouri, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico, Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
University of Rochester Medical Center @ Monroe Community Hospital
🇺🇸Rochester, New York, United States
Senior Adults Specialty Research (SASR)
🇺🇸Austin, Texas, United States
Alliance Research Group, LLC
🇺🇸Richmond, Virginia, United States
University of Wisconson Medical School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
AVI Clinical Research
🇺🇸Carson, California, United States
JEM Research, LLC
🇺🇸Atlantis, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States