Bapineuzumab hos patienter med let til moderat Alzheimers sygdom (ApoE4-bærer)
30. oktober 2013 opdateret af: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Et fase 3, multicenter, randomiseret, dobbeltblindet, placebokontrolleret, parallelgruppe-, effektivitets- og sikkerhedsforsøg med Bapineuzumab (AAB-001, ELN115727) hos patienter med let til moderat Alzheimers sygdom, som er bærere af apolipoprotein E4.
Dette er et multicenter, dobbeltblindt, placebokontrolleret, randomiseret, ambulant, flerdosisstudie med mandlige og kvindelige patienter i alderen 50 til under 89 år med mild til moderat AD. Cirka 200 studiesteder i USA og Canada vil være involveret. Patienter vil blive randomiseret til at modtage enten bapineuzumab eller placebo. Hver patients deltagelse varer cirka 1,5 år.
Bapineuzumab er et humaniseret monoklonalt antistof, som binder til og fjerner beta-amyloid-peptidet og er designet til at give antistoffer mod beta-amyloid direkte til patienten.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1121
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- University of Alabama Hospital (UAB)
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Arizona
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Goodyear, Arizona, Forenede Stater, 85395
- Dedicated Clinical Research, Inc.
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Phoenix, Arizona, Forenede Stater, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Forenede Stater, 85050
- HOPE Research Institute, LLC
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Sun City, Arizona, Forenede Stater, 85351
- Banner Research Institute
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Tucson, Arizona, Forenede Stater, 85724
- University of Arizona College of Medicine, Health Sciences Center
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Tucson, Arizona, Forenede Stater, 85741
- Northwest NeuroSpecialists, PLLC
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Clinical Trials Inc.
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California
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Berkeley, California, Forenede Stater, 94705
- East Bay Physicians Medical Group
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Carson, California, Forenede Stater, 90746
- AVI Clinical Research
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Costa Mesa, California, Forenede Stater, 92626
- ATP Clinical Research, Inc
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Encino, California, Forenede Stater, 91316
- Pharmacology Research Institute
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Fresno, California, Forenede Stater, 93720
- Margolin Brain Institute
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Fullerton, California, Forenede Stater, 92835
- Neurology Center of North Orange County
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La Jolla, California, Forenede Stater, 92037
- University of California San Diego
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La Jolla, California, Forenede Stater, 92037
- Coordinated Clinical Research
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Laguna Hills, California, Forenede Stater, 92653
- Senior Clinical Trials, Inc
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Long Beach, California, Forenede Stater, 90806
- Collaborative Neuroscience Network, Inc.
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Los Alamitos, California, Forenede Stater, 90720
- Pharmacology Research Institute
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Los Angeles, California, Forenede Stater, 90095
- UCLA Department of Neurology
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Los Angeles, California, Forenede Stater, 90035
- Vintage Institute for Clinical Research, Inc
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Newport Beach, California, Forenede Stater, 92660
- Pharmacology Research Institute
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Oceanside, California, Forenede Stater, 92056
- Neurology Center
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Orange, California, Forenede Stater, 92868
- University of California Irvine Medical Center
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Pasadena, California, Forenede Stater, 91105
- Neuro-Therapeutics Inc.
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Sacramento, California, Forenede Stater, 95816
- Sutter Neuroscience Medical Group
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Alzheimer's Disease Research Center
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San Diego, California, Forenede Stater, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Forenede Stater, 92123
- Artemis Institute for Clinical Research
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San Francisco, California, Forenede Stater, 94109
- San Francisco Clinical Research Center
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San Francisco, California, Forenede Stater, 94117
- University of California at San Francisco Medical Center at Parnassus
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Santa Monica, California, Forenede Stater, 90404
- Neurological Research Institute
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Sherman Oaks, California, Forenede Stater, 91403
- Schuster Medical Research Institute
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Walnut Creek, California, Forenede Stater, 94598
- Diablo Clinical Research, Inc.
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Colorado
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Boulder, Colorado, Forenede Stater, 80304
- Alpine Clinical Research Center
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Denver, Colorado, Forenede Stater, 80218
- Mile High Research Center
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Fort Collins, Colorado, Forenede Stater, 80528
- Advanced Neurosciences Research, LLC
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Connecticut
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Danbury, Connecticut, Forenede Stater, 06810
- Associated Neurologists, PC
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Fairfield, Connecticut, Forenede Stater, 06824
- Associated Neurologists of Southern CT, P.C.
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University School Of Medicine
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New Haven, Connecticut, Forenede Stater, 06510
- Institute for Neurodegenerative Disorders
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Norwalk, Connecticut, Forenede Stater, 06851
- Research Center for Clinical Studies, Inc
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Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research, LLC
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20057
- Georgetown University Medical Center
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Florida
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Atlantis, Florida, Forenede Stater, 33462
- JEM Research, LLC
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Bradenton, Florida, Forenede Stater, 34205
- Bradenton Research Center, Inc
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Deerfield Beach, Florida, Forenede Stater, 33064
- Quantum Laboratories, Inc.
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Delray Beach, Florida, Forenede Stater, 33445
- Brain Matters Research
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Neurologic Consultants, P.A.
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Fort Myers, Florida, Forenede Stater, 33916
- Clinical Physiology Associates, Inc.
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Fort Walton Beach, Florida, Forenede Stater, 32547
- Emerald Coast Mood & Memory, PA.
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Ft. Myers, Florida, Forenede Stater, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hallandale Beach, Florida, Forenede Stater, 33009
- MD Clinical
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic College of Medicine
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Maitland, Florida, Forenede Stater, 32751
- Neurology Associates
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Melbourne, Florida, Forenede Stater, 32901
- Melbourne Internal Medicine Associates, MIMA
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Miami, Florida, Forenede Stater, 33137
- Miami Jewish Health Systems
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Miami, Florida, Forenede Stater, 33126
- Pharmax Research Clinic, LLC
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Miami, Florida, Forenede Stater, 33156
- Allied Clinical Trials, Inc.
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Ocala, Florida, Forenede Stater, 34471
- Renstar Medical Research
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Orlando, Florida, Forenede Stater, 32806
- Compass Research, LLC
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Palm Beach Gardens, Florida, Forenede Stater, 33418
- Palm Beach Neurological Center/Advanced Research Consultants
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Port Charlotte, Florida, Forenede Stater, 33952
- Neurostudies, Inc
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Sarasota, Florida, Forenede Stater, 34243
- The Roskamp Institute, Inc
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South Miami, Florida, Forenede Stater, 33143
- Miami Research Associates
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St Petersburg, Florida, Forenede Stater, 33713
- Suncoast Neuroscience Associates, Inc.
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St. Petersburg, Florida, Forenede Stater, 33709
- Meridien Research
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Tampa, Florida, Forenede Stater, 33609
- Axiom Clinical Research of Florida
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Tampa, Florida, Forenede Stater, 33613
- Stedman Clinical Trials, LLC
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Tampa, Florida, Forenede Stater, 33613
- Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
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Tampa, Florida, Forenede Stater, 33613
- University of South Florida Suncoast Alzheimer's and Gerontology Center
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West Palm Beach, Florida, Forenede Stater, 33407
- Premiere Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- NeuroTrials Research, Inc.
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University, School of Medicine
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Atlanta, Georgia, Forenede Stater, 30327
- Multiple Sclerosis Center of Atlanta
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Columbus, Georgia, Forenede Stater, 31909
- Medical Research and Health Educational Foundation, Inc
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Decatur, Georgia, Forenede Stater, 30033
- Dekalb Neurology Associates, LLC
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Lawrenceville, Georgia, Forenede Stater, 30045
- Gwinnett Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University Of Chicago Medical Center
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Elk Grove Village, Illinois, Forenede Stater, 60007
- Alexian Brothers Neurosciences Institute
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Springfield, Illinois, Forenede Stater, 62794
- Southern Illinois University, School of Medicine
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Indiana
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Elkhart, Indiana, Forenede Stater, 46514
- Elkhart Clinic, LLC
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University School of Medicine
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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Lenexa, Kansas, Forenede Stater, 66214
- Mid America Neuroscience Institute
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky
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Lexington, Kentucky, Forenede Stater, 40513
- Associates in Neurology, PSC
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Paducah, Kentucky, Forenede Stater, 42003
- Four Rivers Clinical Research, Inc
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70629
- Lake Charles Clinical Trials
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Shreveport, Louisiana, Forenede Stater, 71104
- J. Gary Booker, MD, APMC
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Shreveport, Louisiana, Forenede Stater, 70112
- Louisiana State University Health Sciences Center
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Maine
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Scarborough, Maine, Forenede Stater, 04074
- Maine Medical Partners Neurology
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins University School Of Medicine
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Massachusetts
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Belmont, Massachusetts, Forenede Stater, 02478
- Mclean Hospital
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University School of Medicine
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Haverhill, Massachusetts, Forenede Stater, 01830
- Activmed Practices and Research, Inc
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Newton, Massachusetts, Forenede Stater, 02459
- Neurocare, Inc
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Pittsfield, Massachusetts, Forenede Stater, 01201
- Neuroscience Research of the Berkshires
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Plymouth, Massachusetts, Forenede Stater, 02360
- Donald S. Marks, MD, P.C.
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Springfield, Massachusetts, Forenede Stater, 01104
- Springfield Neurology Associates
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48105
- University of Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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East Lansing, Michigan, Forenede Stater, 48824
- Michigan State University
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Grand Rapids, Michigan, Forenede Stater, 49503
- Saint Mary's Health Care
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Kalamazoo, Michigan, Forenede Stater, 49048
- Borgess Medical Center/Borgess Research Institute
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Hattiesburg Clinic
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Missouri
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Kansas City, Missouri, Forenede Stater, 64114
- The Center for Pharmaceutical Research
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Kansas City, Missouri, Forenede Stater, 64111
- Saint Luke's Hospital, Mid America Brain and Stroke Institute
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St. Louis, Missouri, Forenede Stater, 63108
- Washington University School of Medicine
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St. Louis, Missouri, Forenede Stater, 63104
- St. Louis University School of Medicine
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Montana
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Billings, Montana, Forenede Stater, 59101
- Deaconess Billings Clinical Research Center
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Great Falls, Montana, Forenede Stater, 59405
- Advanced Neurology Specialists
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198-2045
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- Cleveland Clinic Lou Ruvo Center for Brain Health
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New Jersey
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Eatontown, New Jersey, Forenede Stater, 07724
- Memory Enhancement Center of America, Inc.
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Manchester, New Jersey, Forenede Stater, 08759
- Alzheimer's Research Corporation (ARC)
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Mount Arlington, New Jersey, Forenede Stater, 07856
- The NeuroCognitive Institute
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Princeton, New Jersey, Forenede Stater, 08540
- Princeton Medical Institute
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Stratford, New Jersey, Forenede Stater, 08084
- University of Medicine and Dentistry of New Jersey
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Albuquerque Neuroscience, Inc.
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New York
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Albany, New York, Forenede Stater, 12205
- Upstate Clinical Research, LLC
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Albany, New York, Forenede Stater, 12208
- Neuroscience Research Center at Albany Medical Center
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Albany, New York, Forenede Stater, 12208
- Neurological Associates Albany PC
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Cedarhurst, New York, Forenede Stater, 11516
- Five Towns Neuroscience Research
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Elmsford, New York, Forenede Stater, 10523
- Advanced BioBehavioral Sciences
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Latham, New York, Forenede Stater, 12110
- Empire Neurology, PC
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Liverpool, New York, Forenede Stater, 13088
- Neurological Care of CNY
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New Hyde Park, New York, Forenede Stater, 11040
- Parker Jewish Institute for Health Care & Rehabilitation
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
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New York, New York, Forenede Stater, 10029
- Mt. Sinai School of Medicine
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New York, New York, Forenede Stater, 10016
- NYU School of Medicine/Psychiatry
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Orangeburg, New York, Forenede Stater, 10962
- Nathan S. Kline Institute for Psychiatric Research
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Rochester, New York, Forenede Stater, 14620
- University of Rochester Medical Center @ Monroe Community Hospital
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Hickory, North Carolina, Forenede Stater, 28601
- Clinical Trials of America, Inc
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Hickory, North Carolina, Forenede Stater, 28601
- New Hope Clinical Research
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Raleigh, North Carolina, Forenede Stater, 27607
- Raleigh Neurology Associates
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
- University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
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Canton, Ohio, Forenede Stater, 44718
- Neuro-Behavioral Clinical Research, Inc
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Canton, Ohio, Forenede Stater, 44718
- NeuroCare Center, Inc
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University
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Dayton, Ohio, Forenede Stater, 45417
- Neurology Specialists, Inc.
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Lynn Health Science Institute
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Red River Medical Research Center, LLC
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Oregon
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Medford, Oregon, Forenede Stater, 97504
- Providence Medical Group-Medford Neurology
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Sciences University
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Portland, Oregon, Forenede Stater, 97225
- Providence Health Service System, AD Center, Brain Institute
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Portland, Oregon, Forenede Stater, 97210
- Summit Research Group, LLC
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Abington Neurological Assoc
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Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Health Network
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Jenkintown, Pennsylvania, Forenede Stater, 19046
- The Clinical Trial Center, LLC
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Philadelphia, Pennsylvania, Forenede Stater, 19102
- Drexel University College of Medicine
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Penn Memory Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Jefferson Hospital for Neuroscience
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Pittsburgh, Pennsylvania, Forenede Stater, 15206
- Clinical Trials Research Services, LLC
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Virginia
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Universtiy of Pittsburgh
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Rhode Island
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East Providence, Rhode Island, Forenede Stater, 02914
- Rhode Island mood and memory research institute
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
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Providence, Rhode Island, Forenede Stater, 02906
- Butler Hospital
-
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South Carolina
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N. Charleston, South Carolina, Forenede Stater, 29406
- Medical University of South Carolina
-
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Research Institute
-
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Tennessee
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Cordova, Tennessee, Forenede Stater, 38018
- Neurology Clinic, PC
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Franklin, Tennessee, Forenede Stater, 37067
- Psychiatric Consultants, PC
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Johnson City, Tennessee, Forenede Stater, 37614-1707
- East Tennessee State University
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Knoxville, Tennessee, Forenede Stater, 37920
- Volunteer Research Group
-
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Texas
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Dallas, Texas, Forenede Stater, 75214
- Texas Neurology, PA
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Fort Worth, Texas, Forenede Stater, 76106
- University of North Texas/Health Sciences Center-Fort Worth
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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San Antonio, Texas, Forenede Stater, 78229
- Innovative Clinical Trials
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San Antonio, Texas, Forenede Stater, 78231
- Integra Clinical Research, Llc
-
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Wasatch Clinical Research
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Salt Lake City, Utah, Forenede Stater, 84108
- University of Utah, Dept. of Neurology
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Vermont
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Bennington, Vermont, Forenede Stater, 05201
- The Memory Clinic
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care
-
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Virginia
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Alexandria, Virginia, Forenede Stater, 22304
- Innovative Clinical Research Center
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Richmond, Virginia, Forenede Stater, 23230
- Alliance Research Group, LLC
-
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Washington
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Seattle, Washington, Forenede Stater, 98108
- University of Washington Veterans Affairs
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Seattle, Washington, Forenede Stater, 98144
- Pacific Medical Centers
-
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin School of Medicine and Public Health
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 88 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Diagnose af sandsynlig AD
- Alder fra 50 til under 89
- Mini-Mental Status Eksamen score på 16-26 inklusive
- Hjernemagnetisk resonansbilleddannelse (MRI)-scanning i overensstemmelse med diagnosen AD
- Stabile doser af medicin (cholinesterasehæmmere og memantin tilladt)
- Pårørende kan deltage i alle klinikbesøg med patienten
Ekskluderingskriterier:
- Signifikant neurologisk sygdom bortset fra AD
- Større psykiatrisk lidelse
- Betydelig systemisk sygdom
- Anamnese med slagtilfælde eller anfald, autoimmun sygdom, myokardieinfarkt inden for de sidste 2 år
- Ryger mere end 20 cigaretter om dagen
- Antikonvulsiva, anti-Parkinson, antikoagulerende eller narkotiske medicin
- Forudgående behandling eksperimentel immunterapi eller vacciner mod AD
- Kvinder i den fødedygtige alder
- Tilstedeværelse af pacemakere, CSF-shunts eller fremmede metalgenstande i øjnene, huden eller kroppen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bapineuzumab 0,5 mg/kg
infusion hver 13. uge for i alt 6 infusioner
|
givet som infusion hver 13. uge i i alt 6 infusioner.
Andre navne:
|
|
Eksperimentel: Bapineuzumab 1,0 m/kg
infusion hver 13. uge for i alt 6 infusioner.
|
givet som infusion hver 13. uge i i alt 6 infusioner.
Andre navne:
|
|
Placebo komparator: Placebo dosis
infusion hver 13. uge for i alt 6 infusioner.
|
givet som infusion hver 13. uge i i alt 6 infusioner.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Kognitiv og funktionel
Tidsramme: 18 måneder
|
18 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Kognitiv og global
Tidsramme: 18 måneder
|
18 måneder
|
|
Billeddannelse og biokemiske biomarkører for sygdomsstatus
Tidsramme: 18 måneder
|
18 måneder
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Brashear HR, Ketter N, Bogert J, Di J, Salloway SP, Sperling R. Clinical Evaluation of Amyloid-Related Imaging Abnormalities in Bapineuzumab Phase III Studies. J Alzheimers Dis. 2018;66(4):1409-1424. doi: 10.3233/JAD-180675.
- Ketter N, Brashear HR, Bogert J, Di J, Miaux Y, Gass A, Purcell DD, Barkhof F, Arrighi HM. Central Review of Amyloid-Related Imaging Abnormalities in Two Phase III Clinical Trials of Bapineuzumab in Mild-To-Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;57(2):557-573. doi: 10.3233/JAD-160216.
- Samtani MN, Xu SX, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease assessment scale-cognitive 11-item progression model in mild-to-moderate Alzheimer's disease trials of bapineuzumab. Alzheimers Dement (N Y). 2015 Oct 9;1(3):157-169. doi: 10.1016/j.trci.2015.09.001. eCollection 2015 Nov.
- Liu E, Schmidt ME, Margolin R, Sperling R, Koeppe R, Mason NS, Klunk WE, Mathis CA, Salloway S, Fox NC, Hill DL, Les AS, Collins P, Gregg KM, Di J, Lu Y, Tudor IC, Wyman BT, Booth K, Broome S, Yuen E, Grundman M, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Amyloid-beta 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. Neurology. 2015 Aug 25;85(8):692-700. doi: 10.1212/WNL.0000000000001877. Epub 2015 Jul 24.
- Xu SX, Samtani MN, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease progression model using disability assessment for dementia scores from bapineuzumab trials. Alzheimers Dement (N Y). 2015 Jul 21;1(2):141-149. doi: 10.1016/j.trci.2015.06.005. eCollection 2015 Sep.
- Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, Sabbagh M, Honig LS, Porsteinsson AP, Ferris S, Reichert M, Ketter N, Nejadnik B, Guenzler V, Miloslavsky M, Wang D, Lu Y, Lull J, Tudor IC, Liu E, Grundman M, Yuen E, Black R, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):322-33. doi: 10.1056/NEJMoa1304839.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2007
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
10. december 2007
Først indsendt, der opfyldte QC-kriterier
13. december 2007
Først opslået (Skøn)
17. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. november 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. oktober 2013
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ELN115727-302
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