Bapineuzumab hos patienter med let til moderat Alzheimers sygdom (ApoE4 non-carrier)
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 apolipoprotein E4 ikke-bærere.
Dette er et multicenter, dobbeltblindt, placebokontrolleret, randomiseret, ambulant multipeldosis-studie hos mandlige og kvindelige patienter i alderen 50 til under 89 år med mild til moderat AD. Cirka 230 studiesteder i USA og Canada og op til 35 steder uden for Nordamerika 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)
1331
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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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary, Foothills Medical Centre
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British Columbia
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Kamloops, British Columbia, Canada, V2C 1K7
- Medical Arts Health Research Group
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Kelowna, British Columbia, Canada, V1Y 3G8
- Medical Arts Health Research Group
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Penticton, British Columbia, Canada, V2A 5C8
- Medical Arts Health Research Group
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Vancouver, British Columbia, Canada, V5Z 3T7
- University of British Columbia (UBC) Hospital
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Ontario
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Kingston, Ontario, Canada, K7L 5G2
- Hotel Dieu Hospital/Queens University Memorial Clinics
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London, Ontario, Canada, N6C 5J1
- Parkwood Hospital
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London, Ontario, Canada, N6A 4V2
- Saint Joseph's Health Care London, Saint Joseph's Hospital
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Ottawa, Ontario, Canada, K1N 5C8
- Bruyere Continuing Care
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Peterborough, Ontario, Canada, K9H 2P4
- Kawartha Regional Memory Clinic
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Toronto, Ontario, Canada, M6M 3Z5
- Toronto Centre for Memory and Aging
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Toronto, Ontario, Canada, M3B 2S7
- Neurology Research Inch./Toronto Memory Program
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Whitby, Ontario, Canada, L1N 5S9
- Ontario Shores Centre for Mental Health Scienes
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2J2
- Neuro Rive-Sud Memory Clinic
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Montreal, Quebec, Canada, H1T 2M4
- Hopital Maisonneuve-Rosemont, Comite d' ethique de la recherche
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Montréal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Sherbrooke, Quebec, Canada, JIH 1Z1
- Diex Research Sherbrooke Inc.
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Verdun, Quebec, Canada, H4H 1R3
- Douglas Mental Health University Institute
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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, 85741
- Northwest NeuroSpecialists, PLLC
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Tucson, Arizona, Forenede Stater, 85724-5023
- University of Arizona College of Medicine, Health Science Center
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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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Glendale, California, Forenede Stater, 91204
- Integrated Medical and Behavioral Associates
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Imperial, California, Forenede Stater, 92251
- Sun Valley Behavioral Medical Center
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La Jolla, California, Forenede Stater, 92037
- Coordinated Clinical Research
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La Jolla, California, Forenede Stater, 92037
- University of California San Diego/Shela Marcos Alzheimer's Disease Research Center
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Laguna Hills, California, Forenede Stater, 92653
- Senior Clinical Trials
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Long Beach, California, Forenede Stater, 90806
- Collaborative Neuroscience Network
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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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National City, California, Forenede Stater, 91950
- Synergy Research
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Newport Beach, California, Forenede Stater, 92660
- Pharmacology Research Institute
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Oceanside, California, Forenede Stater, 92056
- The 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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Rancho Mirage, California, Forenede Stater, 92270
- The Southwest Institute for Clinical Research, 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 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, San Francisco
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Santa Ana, California, Forenede Stater, 92701
- Neuropsychiatric Research Center of Orange County
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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
- Institute for Neurodegenerative Disorders
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University School of Medicine, Alzheimer's Disease Research Unit
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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, Inc.
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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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Hollywood, Florida, Forenede Stater, 33021
- Sunrise Clinical Research, Inc.
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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 International 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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Orange City, Florida, Forenede Stater, 32763
- Medical Research Group of Central Florida
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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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Pembroke Pines, Florida, Forenede Stater, 33026
- Broward Research Group, Inc.
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Port Charlotte, Florida, Forenede Stater, 33952
- Neurostudies, Inc
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Sarasota, Florida, Forenede Stater, 34243
- Roskamp Institute
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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
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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, 30327
- Ms Center Of Atlanta
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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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Columbus, Georgia, Forenede Stater, 31909
- Medical Research and Health Education Foundation, Inc.
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Decatur, Georgia, Forenede Stater, 30033
- DeKalb Neurology Associates
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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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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Feinberg School of Medicine
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Elk Grove Village, Illinois, Forenede Stater, 60007
- Alexian Brothers Neurosciences Institute
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Peoria, Illinois, Forenede Stater, 61602
- Methodist Medical Center of Illinois
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Springfield, Illinois, Forenede Stater, 62794-9643
- 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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Fort Wayne, Indiana, Forenede Stater, 46805
- Fort Wayne Neurological Center
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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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Kansas City, Kansas, Forenede Stater, 66112
- Kansas Multi-Specialist Group
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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
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70629
- Lake Charles Clinical Trials
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New Orleans, Louisiana, Forenede Stater, 70114
- Louisiana Research Associates, Inc.
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Shreveport, Louisiana, Forenede Stater, 71104
- J. Gary Booker, MD, APMC
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Shreveport, Louisiana, Forenede Stater, 70112
- Louisana 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 School of Medicine
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Rockville, Maryland, Forenede Stater, 20850
- CBH Health, LLC
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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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Springfield, Massachusetts, Forenede Stater, 01104
- Memory Wellness Clinic
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Weymouth, Massachusetts, Forenede Stater, 02190
- Coastal Research Associates, Inc.
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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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Flowood, Mississippi, Forenede Stater, 39232
- Precise Research Centers
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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
- 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 Hampshire
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Dover, New Hampshire, Forenede Stater, 03820
- Coastal Neurology, PA
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center, Dept of Neurology
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New Jersey
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Berlin, New Jersey, Forenede Stater, 08009
- Comprehensive Clinical Research
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Eatontown, New Jersey, Forenede Stater, 07724
- The 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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Toms River, New Jersey, Forenede Stater, 08755
- Shore Neurology, P.A.
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Albuquerque Neuroscience, Inc.
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Albuquerque, New Mexico, Forenede Stater, 87131
- University of New Mexico, Health Sciences Center
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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 of Albany, P.C.
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Brooklyn, New York, Forenede Stater, 11235
- Social Psychiatry Research Institute
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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 Bio-Behavioral 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, 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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New York, New York, Forenede Stater, 10032
- Columbia University/Medical Center
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New York, New York, Forenede Stater, 14226
- Dent Neurologic Institute
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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, 44125
- Rakesh Ranjan, M.D. & Associates, Inc.
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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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Cleveland, Ohio, Forenede Stater, 44120
- University Memory and Aging Center University Hospitals of Cleveland/Case Medical Center
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
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Dayton, Ohio, Forenede Stater, 45417
- Neurology Specialists, Inc.
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Toledo, Ohio, Forenede Stater, 43623
- Neurology and Neuroscience Center of Ohio
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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, Inc.
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Abington Neurological Associates, LTD
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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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Pittsburg, Pennsylvania, Forenede Stater, 15206
- Clinical Trials Research Services, LLC
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University 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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Austin, Texas, Forenede Stater, 78757
- Senior Adults Specialty Research (Sasr)
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Dallas, Texas, Forenede Stater, 75214
- Texas Neurology, PA
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Dallas, Texas, Forenede Stater, 75390
- University of Texas Southwestern Medical Center at Dallas
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DeSoto, Texas, Forenede Stater, 75115
- Insite clinical research
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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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Houston, Texas, Forenede Stater, 77008
- Claghorn-Lesem Research Clinic, Ltd.
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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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Wichita Falls, Texas, Forenede Stater, 76309
- Grayline Clinical Drug Trials, Inc
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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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Charlottesville, Virginia, Forenede Stater, 22903
- University of Virginia
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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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Wenatchee, Washington, Forenede Stater, 98801
- Wenatchee Valley Medical Center
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconson Medical School of Medicine and Public Health
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Waukesha, Wisconsin, Forenede Stater, 53188
- Independent Pyschiatric Consultants
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Hamburg, Tyskland, 20246
- UKE Hamburg
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Baden-Württemberg
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Freiburg, Baden-Württemberg, Tyskland, 79106
- Universitätsklinik Freiburg
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Baden-wuerttemberg
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Tübingen, Baden-wuerttemberg, Tyskland, 72076
- Universitätsklinik Tübingen
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Ulm, Baden-wuerttemberg, Tyskland, 89081
- Universitätsklinik Ulm
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Bayern
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Günzburg, Bayern, Tyskland, 89312
- Universitätsklinikum Ulm
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München, Bayern, Tyskland, 81675
- Klinikum rechts der Isar der Technischen Universität München
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München, Bayern, Tyskland, 80336
- Ludwig-Maximilians-Universität München
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Byern
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Regensburg, Byern, Tyskland, 93053
- Universitätsklinikum Regensburg
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Nordrhein-westfalen
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Bochum, Nordrhein-westfalen, Tyskland, 44791
- Saint Josefs Hospital
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Saarland
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Homburg/Saar, Saarland, Tyskland, 66421
- Universitatsklinikum des Saarlandes
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Sachen
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Leipzig, Sachen, Tyskland, 04107
- AFL Arzneimittelforschung Leipzig GmbH
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Saschen
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Dresden, Saschen, Tyskland, 01307
- ABX-CRO advanced pharmaceutical services Forschungsgesellschaft GmbH
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Styria
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Graz, Styria, Østrig, 8036
- Medizinische Universität Graz
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Vienna
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Wien, Vienna, Østrig, 1090
- Medizinische Universität Wien
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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 |
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Eksperimentel: Bapineuzumab 0,5 mg/kg
infusion hver 13. uge for i alt 6 infusioner
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infusion hver 13. uge for i alt 6 infusioner
Andre navne:
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Placebo komparator: Placebo kontrol
infusion hver 13. uge for i alt 6 infusioner.
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givet som infusion hver 13. uge i i alt 6 infusioner.
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Eksperimentel: Bapineuzumab 1,0 m/kg
infusion hver 13. uge for i alt 6 infusioner.
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infusion hver 13. uge for i alt 6 infusioner
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Kognitiv og funktionel
Tidsramme: 18 måneder
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18 måneder
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Kognitiv og global
Tidsramme: 18 måneder
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18 måneder
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Billeddannelse og biokemiske biomarkører for sygdomsstatus
Tidsramme: 18 måneder
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18 måneder
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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. juni 2012
Studieafslutning (Faktiske)
1. juni 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
- ELN115727-301
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .