A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT00937352
- Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 896
- Diagnosis of probable AD
- 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
- Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bapineuzumab 1.0 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 0.5 mg/kg
- Primary Outcome Measures
Name Time Method Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments. Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD. The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first
Trial Locations
- Locations (188)
Melbourne Internal Medicine Associates
🇺🇸Melbourne, Florida, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Penn Memory Center
🇺🇸Philadelphia, Pennsylvania, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Medical Arts Health Research Group
🇨🇦Kelowna, British Columbia, Canada
UCLA Department of Neurology
🇺🇸Los Angeles, California, 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
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Washington Veterans Affairs
🇺🇸Seattle, Washington, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Pharmax Research Clinic, LLC
🇺🇸Miami, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Allied Clinical Trials Inc.
🇺🇸Miami, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Red River Medical Research Center, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Psychiatric Consultants, PC
🇺🇸Nashville, Tennessee, 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
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
University of Alabama Hospital
🇺🇸Birmingham, Alabama, United States
Neurology Research Inc
🇨🇦Toronto, Ontario, Canada
Toronto Centre for Memory and Aging
🇨🇦Toronto, Ontario, Canada
Mile High Research Center
🇺🇸Denver, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Summit Research Group, LLC
🇺🇸Portland, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
Medical Research and Health Education Foundation, Inc.
🇺🇸Columbus, Georgia, United States
Rhode Island Mood and Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Associated Neurologists, PC
🇺🇸Danbury, Connecticut, United States
Neurologic Consultants, PA
🇺🇸Fort Lauderdale, Florida, United States
Sutter Neuroscience Medical Group
🇺🇸Sacramento, California, United States
Diablo Clinical Research, Inc
🇺🇸Walnut Creek, California, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Neurology Center
🇺🇸Oceanside, California, United States
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
🇺🇸Tampa, Florida, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Quantum Laboratories, Inc.
🇺🇸Deerfield Beach, Florida, United States
University of South Florida Suncoast Alzheimer's and Gerontology Center
🇺🇸Tampa, Florida, United States
Clinical Physiology Associates, Inc
🇺🇸Fort Myers, Florida, United States
Suncoast Neuroscience Associates, Inc.
🇺🇸Saint Petersburg, Florida, United States
The Roskamp Institute, Inc
🇺🇸Sarasota, Florida, United States
CBH Health, LLC
🇺🇸Rockville, Maryland, United States
Brigham and Women's Hospital, Dept. of Neurology
🇺🇸Boston, Massachusetts, United States
Global Medical Institutes, LLC
🇺🇸Princeton, New Jersey, United States
Neurological Associates of Albany, PC
🇺🇸Albany, New York, United States
Providence Medical Group-Medford Neurology
🇺🇸Medford, Oregon, United States
Jefferson Hospital for Neuroscience
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State University, Dept. of Neurology
🇺🇸Columbus, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Providence Health Service System, AD Center, Brain Institute
🇺🇸Portland, Oregon, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dept. of Neurology
🇺🇸Dallas, Texas, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Independent Psychiatric Consultants
🇺🇸Waukesha, Wisconsin, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Innovative Clinical Research Center
🇺🇸Alexandria, Virginia, United States
Douglas Mental Health University Institute
🇨🇦Verdun, Quebec, Canada
Sir Mortimer B. Davis, Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Ontario Shores Centre for Mental Health Sciences
🇨🇦Whitby, Ontario, Canada
Bruyere Continuing Care
🇨🇦Ottawa, Ontario, Canada
Pacific Medical Centers
🇺🇸Seattle, Washington, United States
Parkwood Hospital
🇨🇦London, Ontario, Canada
Queens University Memorial Clinics
🇨🇦Kingston, Ontario, Canada
Neuro Rive-Sud Memory Clinic
🇨🇦Greenfield Park, Quebec, Canada
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Abington Neurological Associates, Ltd.
🇺🇸Abington, Pennsylvania, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Neuro-Therapeutics, Inc.
🇺🇸Pasadena, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Research Center for Clinical Studies, Inc.
🇺🇸Norwalk, Connecticut, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
JEM Research, LLC
🇺🇸Atlantis, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Alliance Research Group, LLC
🇺🇸Richmond, Virginia, United States
Christiana Care Neurology Specialists
🇺🇸Newark, Delaware, United States
Emerald Coast Mood and Memory, PA.
🇺🇸Fort Walton Beach, Florida, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
🇺🇸Palm Beach Gardens, Florida, United States
Neuroscience Research Center at Albany Medical Center
🇺🇸Albany, New York, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Dedicated Clinical Research, Inc.
🇺🇸Goodyear, Arizona, United States
Banner Research Institute
🇺🇸Sun City, Arizona, United States
East Bay Physicians Medical Group
🇺🇸Berkeley, California, United States
Northwest NeuroSpecialists, PLLC
🇺🇸Tucson, Arizona, United States
AVI Clinical Research
🇺🇸Carson, California, United States
University of Arizona College of Medicine, Health Sciences Center
🇺🇸Tucson, Arizona, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Senior Clinical Trials, Inc.
🇺🇸Laguna Hills, California, United States
Coordinated Clinical Research
🇺🇸La Jolla, California, United States
Collaborative NeuroScience Network, Inc.
🇺🇸Long Beach, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Associated Neurologists of Southern Connecticut, P.C.
🇺🇸Fairfield, Connecticut, United States
University of California at Davis, Alzheimer's Disease Research Center
🇺🇸Sacramento, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Bradenton Research Center, Inc.
🇺🇸Bradenton, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Mayo Clinic College of Medicine
🇺🇸Jacksonville, Florida, United States
Neurology Associates
🇺🇸Maitland, Florida, United States
Neurostudies, Inc.
🇺🇸Port Charlotte, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, 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
Elkhart Clinic, LLC
🇺🇸Elkhart, Indiana, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Alexian Brothers Neuroscience Institute
🇺🇸Elk Grove Village, Illinois, United States
MidAmerica Neuroscience Institute
🇺🇸Lenexa, Kansas, United States
Associates in Neurology, PSC
🇺🇸Lexington, Kentucky, United States
University of Kentucky
🇺🇸Lexington, 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
Springfield Neurology Associates, LLC
🇺🇸Springfield, Massachusetts, United States
Neuroscience Research of the Berkshires
🇺🇸Pittsfield, Massachusetts, United States
ActivMed Practices and Research, Inc.
🇺🇸Haverhill, Massachusetts, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
Donald S. Marks, MD, PC
🇺🇸Plymouth, Massachusetts, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Borgess Medical Center/Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Washington University School of Medicine
🇺🇸Saint Lous, Missouri, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Saint Louis University School of Medicine
🇺🇸Saint 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
🇺🇸Manchester, New Jersey, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Shore Neurology, PA
🇺🇸Toms River, New Jersey, United States
Advanced BioBehavioral Sciences
🇺🇸Elmsford, New York, United States
Nathan S. Kline Institute for Psychiatric Research
🇺🇸Orangeburg, New York, United States
Empire Neurology, PC
🇺🇸Latham, New York, United States
Neurological Care of Central New York
🇺🇸Liverpool, 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
University of Rochester Medical Center, Monroe Community Hospital
🇺🇸Rochester, New York, United States
Parker Jewish Institute for Health Care and Rehabilitation
🇺🇸New Hyde Park, New York, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸Canton, Ohio, United States
Clinical Trials of America, Inc
🇺🇸Hickory, North Carolina, United States
Neurology Specialists, Inc.
🇺🇸Dayton, Ohio, United States
Medical University of South Carolina
🇺🇸North Charleston, South Carolina, United States
Senior Adults Specialty Research (SASR)
🇺🇸Austin, Texas, 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
Butler Hospital
🇺🇸Providence, Rhode Island, United States
University of North Texas Health Science Center at Fort Worth
🇺🇸Fort Worth, Texas, United States
University of Utah, Dept. of Neurology
🇺🇸Salt Lake City, Utah, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Landeskrankenhaus- Universitätsklinikum Graz
🇦🇹Graz, Styria, Austria
Hôpital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
University of Calgary, Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States