A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00937352
Last Updated: 2013-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
896 participants
INTERVENTIONAL
2009-07-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bapineuzumab 0.5 mg/kg
0.5 mg/kg
Bapineuzumab
0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
Bapineuzumab 1.0 mg/kg
1.0 mg/kg
Bapineuzumab
0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
Interventions
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Bapineuzumab
0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
Eligibility Criteria
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Inclusion Criteria
* Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
* Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
* Caregiver able to attend all clinic visits with patient
Exclusion Criteria
* Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
* Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)
51 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Responsible Party
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Locations
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University of Alabama Hospital
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
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
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
Sutter Neuroscience Medical Group
Sacramento, California, United States
University of California at Davis, Alzheimer's Disease Research Center
Sacramento, California, 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 San Francisco
San Francisco, California, United States
Neurological Research Institute
Santa Monica, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Diablo Clinical Research, Inc
Walnut Creek, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Mile High Research Center
Denver, Colorado, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, United States
Associated Neurologists, PC
Danbury, Connecticut, United States
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Christiana Care Neurology Specialists
Newark, Delaware, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
JEM Research, LLC
Atlantis, Florida, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Quantum Laboratories, Inc.
Deerfield Beach, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neurologic Consultants, PA
Fort Lauderdale, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Clinical Physiology Associates, Inc
Fort Myers, Florida, United States
Emerald Coast Mood and Memory, PA.
Fort Walton Beach, Florida, United States
MD Clinical
Hallandale, Florida, United States
Mayo Clinic College of Medicine
Jacksonville, Florida, United States
Neurology Associates
Maitland, Florida, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, 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
Miami Research Associates
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States
Neurostudies, Inc.
Port Charlotte, Florida, United States
The Roskamp Institute, Inc
Sarasota, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 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, LLC
Tampa, Florida, United States
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Emory University, School of Medicine
Atlanta, Georgia, United States
Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Medical Research and Health Education Foundation, Inc.
Columbus, Georgia, United States
Medical Research and Health Education Foundation, Inc
Columbus, Georgia, United States
DeKalb Neurology Associates, LLC
Decatur, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Alexian Brothers Neuroscience Institute
Elk Grove Village, 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
Indiana University School of Medicine
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States
Associates in Neurology, PSC
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
J. Gary Booker, MD, APMC
Shreveport, Louisiana, United States
Maine Medical Partners Neurology
Scarborough, Maine, United States
CBH Health, LLC
Rockville, Maryland, United States
Brigham and Women's Hospital, Dept. of Neurology
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, United States
Neurocare, Inc.
Newton, Massachusetts, United States
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, United States
Donald S. Marks, MD, PC
Plymouth, Massachusetts, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Borgess Medical Center/Borgess Research Institute
Kalamazoo, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Washington University School of Medicine
Saint Lous, Missouri, United States
Saint Louis University School of Medicine
St Louis, Missouri, United States
Deaconess Billings Clinical Research Center
Billings, Montana, United States
Advanced Neurology Specialists
Great Falls, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Alzheimer's Research Corporation
Paterson, New Jersey, United States
Global Medical Institutes, LLC
Princeton, New Jersey, United States
Shore Neurology, PA
Toms River, New Jersey, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States
Upstate Clinical Research, LLC
Albany, New York, United States
Neurological Associates of Albany, PC
Albany, New York, United States
Neuroscience Research Center at Albany Medical Center
Albany, New York, United States
Advanced BioBehavioral Sciences
Elmsford, New York, United States
Empire Neurology, PC
Latham, New York, United States
Neurological Care of Central New York
Liverpool, New York, United States
Parker Jewish Institute for Health Care and Rehabilitation
New Hyde Park, New York, United States
New York University School of Medicine/Psychiarty
New York, New York, United States
Columbia University Medical Center
New York, New York, 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
Duke University Medical Center
Durham, North Carolina, United States
Clinical Trials of America, Inc
Hickory, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Ohio State University, Dept. of Neurology
Columbus, Ohio, United States
Neurology Specialists, Inc.
Dayton, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, United States
Providence Medical Group-Medford Neurology
Medford, Oregon, United States
Summit Research Group, LLC
Portland, Oregon, United States
Providence Health Service System, AD Center, Brain Institute
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Abington Neurological Associates, Ltd.
Abington, Pennsylvania, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Penn Memory Center
Philadelphia, Pennsylvania, United States
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
East Tennessee State University
Johnson City, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Psychiatric Consultants, PC
Nashville, Tennessee, United States
Senior Adults Specialty Research (SASR)
Austin, Texas, United States
Texas Neurology, PA
Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dept. of Neurology
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Integra Clinical Research, LLC
San Antonio, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
University of Utah, Dept. of Neurology
Salt Lake City, Utah, United States
The Memory Clinic
Bennington, Vermont, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Innovative Clinical Research Center
Alexandria, Virginia, United States
University of Virginia
Charlottesville, Virginia, United States
Alliance Research Group, LLC
Richmond, Virginia, United States
University of Washington Veterans Affairs
Seattle, Washington, United States
Pacific Medical Centers
Seattle, Washington, United States
Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States
Landeskrankenhaus- Universitätsklinikum Graz
Graz, Styria, Austria
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada
Medical Arts Health Research Group
Kamloops, British Columbia, Canada
Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Queens University Memorial Clinics
Kingston, Ontario, Canada
Parkwood Hospital
London, Ontario, Canada
Bruyere Continuing Care
Ottawa, Ontario, Canada
Neurology Research Inc
Toronto, Ontario, Canada
Toronto Centre for Memory and Aging
Toronto, Ontario, Canada
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, Canada
Neuro Rive-Sud Memory Clinic
Greenfield Park, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Sir Mortimer B. Davis, Jewish General Hospital
Montreal, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Douglas Mental Health University Institute
Verdun, Quebec, Canada
Countries
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Other Identifiers
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ELN115727-351
Identifier Type: -
Identifier Source: org_study_id