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Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
This study is currently recruiting participants.
Verified by JANSSEN Alzheimer Immunotherapy Research & Development, LLC, September 2009
First Received: December 10, 2007   Last Updated: September 22, 2009   History of Changes
Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00575055
  Purpose

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Bapineuzumab
Drug: Placebo Control
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Drug Information available for: Bapineuzumab
U.S. FDA Resources

Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: December 2007
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Drug: Bapineuzumab
B: Placebo Comparator Drug: Placebo Control

  Eligibility

Ages Eligible for Study:   50 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 16-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575055

Contacts
Contact: Study Coordinator 1-866-446-5463

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Hospital (UAB) Active, not recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Private Practice Active, not recruiting
Scottsdale, Arizona, United States, 85254
Dedicated Clinical Research, Inc. Active, not recruiting
Litchfield Park, Arizona, United States, 85340
Northwest Neurospecialists Active, not recruiting
Tucson, Arizona, United States, 85741
University of Arizona College of Medicine Active, not recruiting
Tucson, Arizona, United States, 85724-5023
Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
United States, Arkansas
Clinical Trials Inc. Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Pharmacology Research Institue Active, not recruiting
Encino, California, United States, 91316
Pharmacology Research Institute Active, not recruiting
Los Alamitos, California, United States, 90720
Pharmacology Research Institute Active, not recruiting
Newport Beach, California, United States, 92660
Sharp Mesa Vista Hospital Recruiting
San Diego, California, United States, 92123
San Francisco Clinical Research Center Active, not recruiting
San Francisco, California, United States, 94109
Bay Area Research Institute Active, not recruiting
Lafayette, California, United States, 94549
Collaborative NeuroScience Network, Inc. Recruiting
Garden Grove, California, United States, 92845
Margolin Brain Institute Active, not recruiting
Fresno, California, United States, 93720
Senior Clinical Trials Active, not recruiting
Laguna Hills, California, United States, 92653
Vintage Institute for Clinical Research, Inc Active, not recruiting
Los Angeles, California, United States, 90036
Private Practice Active, not recruiting
La Jolla, California, United States, 92037
Sutter Neuroscience Institiute Active, not recruiting
Sacramento, California, United States, 95816
AVI Clinical Research Active, not recruiting
Carson, California, United States, 96047
Neurological Research Institute Recruiting
Santa Monica, California, United States, 90404
Neuro-Therapeutics Inc. Active, not recruiting
Pasadena, California, United States, 91105
The Neurology Center Recruiting
Oceanside, California, United States, 92056
UCSF Active, not recruiting
San Francisco, California, United States, 94143-1207
Neurology of North Orange County Recruiting
La Habra, California, United States, 90631
UCLA Department of Neurology Active, not recruiting
Los Angeles, California, United States, 90095
University of California, Irvine Recruiting
Orange, California, United States, 92868
University of California San Diego/Shela Marcos Alzheimer's Disease Research Center Recruiting
San Diego, California, United States, 92037
ATP Clinical Research, Inc Recruiting
Costa Mesa, California, United States, 92626
East Bay Physicians Medical Group Active, not recruiting
Berkeley, California, United States, 94705
UC Davis Alzheimer's Disease Center Active, not recruiting
Sacramento, California, United States, 95817
Artemis Institute for Clinical Research Recruiting
San Diego, California, United States, 92123
United States, Colorado
Associated Neurologists , PC Active, not recruiting
Boulder, Colorado, United States, 80304
Mile High Research Center Active, not recruiting
Denver, Colorado, United States, 80218
Alpine Clinical Research Center Active, not recruiting
Boulder, Colorado, United States, 80304
Advanced Neurosciences Research, LLC Active, not recruiting
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Associated Neurologists of Southern CT, P.C. Active, not recruiting
Fairfield, Connecticut, United States, 06824
Institute for Neurodegenerative Disorders Active, not recruiting
New Haven, Connecticut, United States, 06510
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Associated Neurologists Active, not recruiting
Danbury, Connecticut, United States, 06810
Chase Medical Research, LLC Active, not recruiting
Waterbury, Connecticut, United States, 06708
Research Center for Clinical Studies Active, not recruiting
Norwalk, Connecticut, United States, 06851
United States, Delaware
Neurology Associates Active, not recruiting
Newark, Delaware, United States, 19713
United States, District of Columbia
Georgetown University Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Brain Matters Research, Inc. Active, not recruiting
Delray Beach, Florida, United States, 33445
Palm Beach Neurological Center/Advanced Research Consultants Active, not recruiting
Palm Beach Gardens, Florida, United States, 33418
Allied Clinical Trials, Inc. Active, not recruiting
Miami, Florida, United States, 33156
Axiom Clinical Research of Florida Active, not recruiting
Tampa, Florida, United States, 33609
Compass Research Active, not recruiting
Orlando, Florida, United States, 32806
Emerald Coast Mood & Memory, PA. Active, not recruiting
Fort Walton Beach, Florida, United States, 32547
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute Active, not recruiting
Tampa, Florida, United States, 33647
Miami Jewish Home and Hospital Active, not recruiting
Miami, Florida, United States, 33137
Miami Research Associates Active, not recruiting
South Miami, Florida, United States, 33143
Premiere Research Institute Active, not recruiting
West Palm Beach, Florida, United States, 33407
Roskamp Institute Active, not recruiting
Sarasota, Florida, United States, 34243
Suncoast Neuroscience Associates, Inc. Active, not recruiting
St Petersburg, Florida, United States, 33701
Clinical Physiology Associates, Inc. Active, not recruiting
Fort Myers, Florida, United States, 33916
MD Clinical Active, not recruiting
Hallandale Beach, Florida, United States, 33009
Renstar Medical Research Active, not recruiting
Ocala, Florida, United States, 34471
Neurologic Consultants, P.A. Active, not recruiting
Fort Lauderdale, Florida, United States, 33308
Neurostudies, Inc Active, not recruiting
Port Charlotte, Florida, United States, 33952
Pharmax Research Clinic, LLC Active, not recruiting
Miami, Florida, United States, 33126
University of South Florida Active, not recruiting
Tampa, Florida, United States, 33617
Melbourne International Medicine Associates, MIMA Active, not recruiting
Melbourne, Florida, United States, 32901
Private Practice Active, not recruiting
Atlantis, Florida, United States, 33462
Stedman Clinical Trials Active, not recruiting
Tampa, Florida, United States, 33613
Mayo Clinic College of Medicine Active, not recruiting
Jacksonville, Florida, United States, 32224
Bradenton Research Center, Inc Active, not recruiting
Bradenton, Florida, United States, 34205
Neuropsychiatric Research Center of Southwest Florida Active, not recruiting
Ft. Myers, Florida, United States, 33912
Meridien Research Active, not recruiting
St. Petersburg, Florida, United States, 33709
Quantum Laboratories, Inc. Active, not recruiting
Deerfield Beach, Florida, United States, 33064
Neurology Associates Active, not recruiting
Maitland, Florida, United States, 32751
United States, Georgia
Dekalb Neurology Associates, LLC Recruiting
Decatur, Georgia, United States, 30033
MS Center of Atlanta Active, not recruiting
Atlanta, Georgia, United States, 30327
Emory University Dept of Neurology Recruiting
Atlanta, Georgia, United States, 30322
Dekalb Neurology Associates Recruiting
Decatur, Georgia, United States, 30033
Neuroscience Research Institute at Gwinnett Medical Center Active, not recruiting
Lawrenceville, Georgia, United States, 30045
NeuroTrials Research, Inc. Active, not recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Springfield Clinic Neuroscience Institute Active, not recruiting
Springfield, Illinois, United States, 62702
Southern Illinois University, School of Medicine Active, not recruiting
Springfield, Illinois, United States, 62794-9643
Alexian Brothers Neurosciences Institute Active, not recruiting
Elk Grove Village, Illinois, United States, 60007
University of Chicago Medical Center Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Elkhart Clinic, LLC Active, not recruiting
Elkhart, Indiana, United States, 46514
Indiana University School of Medicine Active, not recruiting
Indianapolis, Indiana, United States, 46202
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Mid America Neuroscience Institute Active, not recruiting
Lenexa, Kansas, United States, 66214
University of Kansas Medical Center, Landon Center for Aging Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Four Rivers Clinical Research Active, not recruiting
Paducah, Kentucky, United States, 42003
Associates in Neurology Active, not recruiting
Lexington,, Kentucky, United States, 40513
University of Kentucky Active, not recruiting
Lexington, Kentucky, United States, 40536
United States, Louisiana
Lake Charles Clinical Trials Active, not recruiting
Lake Charles, Louisiana, United States, 70601
Private Practice Active, not recruiting
Shreveport, Louisiana, United States, 71104
Louisana State University Health Sciences Center Active, not recruiting
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287-2631
University of Maryland - Parkinson's and Movement Disorders Center Active, not recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Neurocare Center for Research Recruiting
Newton, Massachusetts, United States, 02459
Neuroscience Research of the Berkshires Recruiting
Pittsfield, Massachusetts, United States, 01201
Brigham and Women's Hospital Dept of Neurology Recruiting
Boston, Massachusetts, United States, 02115
Geriatric Psychiatry Program McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02360
Donald S. Marks, MD, P.C. Recruiting
Plymouth, Massachusetts, United States, 02360
ActivMed Practices and Research Recruiting
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Summit Research Network, Inc. (Michigan) Active, not recruiting
Okemos, Michigan, United States, 48864
Borgess Medical Center/Borgess Research Institute Active, not recruiting
Kalamazoo, Michigan, United States, 49048
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
University of Michigan Health Systems Dept of Neurology Recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Health Systems Active, not recruiting
Detroit, Michigan, United States, 48202
Saint Mary's Health Care Active, not recruiting
Grand Rapids, Michigan, United States, 49503
University of Michigan, Taubman Health Care Center, Dept. of Neurology Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Rochester Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
Hattiesburg Clinic Active, not recruiting
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
The Center for Pharmaceutical Research Active, not recruiting
Kansas City, Missouri, United States, 64114
St. Louis University School of Medicine Recruiting
St. Louis, Missouri, United States, 63104
Saint Luke's Hospital Active, not recruiting
Kansas City, Missouri, United States, 64111
Washington University School of Medicine Active, not recruiting
St. Louis, Missouri, United States, 63108
United States, Montana
Advanced Neurology Specialists Active, not recruiting
Great Falls, Montana, United States, 59405
Billings Clinical Research Center Active, not recruiting
Billings, Montana, United States, 59101
United States, Nebraska
University of Nebraska Medical Center Active, not recruiting
Omaha, Nebraska, United States, 68198-2045
United States, Nevada
University of Nevada School of Medicine Active, not recruiting
Las Vegas, Nevada, United States, 89102
United States, New Jersey
The Memory Enhancement Center of America, Inc. Active, not recruiting
Long Branch, New Jersey, United States, 07740
Alzheimer's Research Corporation (ARC) Active, not recruiting
Manchester, New Jersey, United States, 08759
Princeton Medical Institute Active, not recruiting
Princeton, New Jersey, United States, 08540
Exodon, LLC Recruiting
Mount Arlington, New Jersey, United States, 07856
University of Medicine and Dentistry of New Jersey Active, not recruiting
Stratford, New Jersey, United States, 08084
United States, New Mexico
Albuquerque Neuroscience, Inc. Active, not recruiting
Albuquerque, New Mexico, United States, 87109
University of New Mexico, Health Sciences Center Active, not recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Neurological Associates Albany PC Active, not recruiting
Albany, New York, United States, 12208
Parker Jewish Institute for Health Care & Rehabilitation Active, not recruiting
New Hyde Park, New York, United States, 10040
University of Rochester Medical Center @ Monroe Community Hospital Active, not recruiting
Rochester, New York, United States, 14620
Upstate Clinical Research, LLC Active, not recruiting
Albany, New York, United States, 12205
Neuroscience Research Center at Albany Medical Center Active, not recruiting
Albany, New York, United States, 12208
Columbia University/Taub Institute for Research Recruiting
New York, New York, United States, 10032
Empire Neurology, PC Active, not recruiting
Latham, New York, United States, 12201
Neurological Care of CNY Active, not recruiting
Syracuse, New York, United States, 13210
NYU Medical Center Active, not recruiting
New York, New York, United States, 10016
Nathan S. Kline Institute for Psychiatric Research Active, not recruiting
Orangeburg, New York, United States, 10962
Five Towns Neuroscience Research Active, not recruiting
Cedarhurst, New York, United States, 11516
Mt. Sinai School of Medicine Active, not recruiting
New York, New York, United States, 10029
United States, North Carolina
Raleigh Neurology Associates Recruiting
Raleigh, North Carolina, United States, 27607
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Clinical Trials of America Recruiting
Hickory, North Carolina, United States, 28601
United States, Ohio
Ohio State University, Dept of Neurology Active, not recruiting
Columbus, Ohio, United States, 43210
University Memory and Aging Center University Hospitals of Cleveland Case Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44120
Neuro-Behavioral Clinical Research, Inc Active, not recruiting
Canton, Ohio, United States, 44708
Neurology Specialists, Inc. Active, not recruiting
Dayton, Ohio, United States, 45408
United States, Oklahoma
Lynn Health Science Institute Active, not recruiting
Oklahoma City, Oklahoma, United States, 73112
Red River Medical Research Active, not recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Summit Research Network, Inc. Active, not recruiting
Portland, Oregon, United States, 97210
Medford Neurological and Spine Center Active, not recruiting
Medford, Oregon, United States, 97504
Providence Health Service System Active, not recruiting
Portland, Oregon, United States, 97222
Oregon Health & Sciences University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
The Clinical Trial Center Recruiting
Jenkintown, Pennsylvania, United States, 19046
Abington Neurological Assoc Recruiting
Abington, Pennsylvania, United States, 19001
Clinical Trials Research Services, LLC Recruiting
Pittsburgh, Pennsylvania, United States, 15206
Lehigh Valley Hospital Active, not recruiting
Allentown, Pennsylvania, United States, 18103
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Jefferson Medical College Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Universtiy of Pittsburgh, Alzheimer Disease Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Penn Comprehensive Neuroscience Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Penn Memory Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Butler Hospital/Brown University Recruiting
Providence, Rhode Island, United States, 02906
Rhode Island Mood and Memory Research Institute Active, not recruiting
East Providence, Rhode Island, United States, 02914
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Active, not recruiting
N. Charleston, South Carolina, United States, 29406
United States, South Dakota
Avera Research Institute Active, not recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Volunteer Research Group Active, not recruiting
Knoxville, Tennessee, United States, 37920
Psychiatric Consultants, PC Active, not recruiting
Nashville, Tennessee, United States, 37203
East Tennessee State University Active, not recruiting
Johnson City, Tennessee, United States, 37614-1707
University of Tennessee Health Science Center Active, not recruiting
Memphis, Tennessee, United States, 38163
United States, Texas
Innovative Clinical Trials Active, not recruiting
San Antonio, Texas, United States, 78229
Synergy Research Active, not recruiting
San Antonio, Texas, United States, 78230
Texas Neurology Active, not recruiting
Dallas, Texas, United States, 75214
University of North Texas/Health Sciences Center-Fort Worth Active, not recruiting
Fort Worth, Texas, United States, 76106
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Integra Clinical Research Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Wasatch Clinical Research Active, not recruiting
Salt Lake City, Utah, United States, 84107
Center for Alzheimers Care, Imaging and Research Active, not recruiting
Salt Lake City, Utah, United States, 84108
United States, Vermont
Clinical Neuroscience Research Associates, Inc-The Memory Clinic Active, not recruiting
Bennington, Vermont, United States, 05201
Fletcher Allen Health Care/Neurology Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Innovative Clinical Research Center Active, not recruiting
Alexandria, Virginia, United States, 22304
Alliance Research Group Active, not recruiting
Richmond, Virginia, United States, 23229
University of Virginia Active, not recruiting
Charlottesville, Virginia, United States, 22903
United States, Washington
Pacific Medical Centers, Beacon Hill Active, not recruiting
Seattle, Washington, United States, 98144
University of Washington/V.A. Active, not recruiting
Seattle, Washington, United States, 98108
United States, Wisconsin
Froedert Lutheran Hospital, Medical College of Wisconsin Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Medical School Recruiting
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC ( VP Clinical Development )
Study ID Numbers: ELN115727-302
Study First Received: December 10, 2007
Last Updated: September 22, 2009
ClinicalTrials.gov Identifier: NCT00575055     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
 Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 27, 2009



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