Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

Last updated: October 30, 2013
Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Dementia

Memory Loss

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT00575055
ELN115727-302
  • Ages 50-88
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Significant neurological disease other than AD

  • Major psychiatric disorder

  • Significant systemic illness

  • History of stroke or seizure, autoimmune disease, myocardial infarction within thelast 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

Study Design

Total Participants: 1121
Study Start date:
December 01, 2007
Estimated Completion Date:
April 30, 2012

Connect with a study center

  • Parkwood Hospital

    London, Ontario N6C 5J1
    Canada

    Site Not Available

  • Neurology Research Inc./Toronto Memory Program

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • Neuro Rive-Sud Memory Clinic

    Greenfield Park, Quebec J4V 2J2
    Canada

    Site Not Available

  • Hôpital Maisonneuve-Rosemont

    Montréal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec J1H 1Z1
    Canada

    Site Not Available

  • University of Alabama Hospital (UAB)

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Dedicated Clinical Research, Inc.

    Goodyear, Arizona 85395
    United States

    Site Not Available

  • Banner Alzheimer's Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • HOPE Research Institute, LLC

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • Banner Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Northwest NeuroSpecialists, PLLC

    Tucson, Arizona 85741
    United States

    Site Not Available

  • University of Arizona College of Medicine, Health Sciences Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Clinical Trials Inc.

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • East Bay Physicians Medical Group

    Berkeley, California 94705
    United States

    Site Not Available

  • AVI Clinical Research

    Carson, California 90746
    United States

    Site Not Available

  • ATP Clinical Research, Inc

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Pharmacology Research Institute

    Encino, California 91316
    United States

    Site Not Available

  • Margolin Brain Institute

    Fresno, California 93720
    United States

    Site Not Available

  • Neurology Center of North Orange County

    Fullerton, California 92835
    United States

    Site Not Available

  • Sun Valley Research Center

    Imperial, California 92251
    United States

    Site Not Available

  • Neurology Center of North Orange County

    La Habra, California 90631
    United States

    Site Not Available

  • Coordinated Clinical Research

    La Jolla, California 92037
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • Senior Clinical Trials, Inc

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Collaborative NeuroScience Network, Inc.

    Long Beach, California 90806
    United States

    Site Not Available

  • Pharmacology Research Institute

    Los Alamitos, California 90720
    United States

    Site Not Available

  • UCLA Department of Neurology

    Los Angeles, California 90095
    United States

    Site Not Available

  • Vintage Institute for Clinical Research, Inc

    Los Angeles, California 90035
    United States

    Site Not Available

  • Pharmacology Research Institute

    Newport Beach, California 92660
    United States

    Site Not Available

  • Neurology Center

    Oceanside, California 92056
    United States

    Site Not Available

  • University of California Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Neuro-Therapeutics Inc.

    Pasadena, California 91105
    United States

    Site Not Available

  • Sutter Neuroscience Medical Group

    Sacramento, California 95816
    United States

    Site Not Available

  • University of California Davis Alzheimer's Disease Research Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92123
    United States

    Site Not Available

  • Sharp Mesa Vista Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • San Francisco Clinical Research Center

    San Francisco, California 94109
    United States

    Site Not Available

  • University of California at San Francisco Medical Center at Parnassus

    San Francisco, California 94117
    United States

    Site Not Available

  • Neurological Research Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Schuster Medical Research Institute

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Alpine Clinical Research Center

    Boulder, Colorado 80304
    United States

    Site Not Available

  • Mile High Research Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Associated Neurologists, PC

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Associated Neurologists of Southern CT, P.C.

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Research Center for Clinical Studies, Inc

    Norwalk, Connecticut 06851
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Christiana Care Health Services

    Newark, Delaware 19713
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • JEM Research, LLC

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Bradenton Research Center, Inc

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Quantum Laboratories, Inc.

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Neurologic Consultants, P.A.

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Clinical Physiology Associates, Inc.

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Emerald Coast Mood & Memory, PA.

    Fort Walton Beach, Florida 32547
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Southwest Florida

    Ft. Myers, Florida 33912
    United States

    Site Not Available

  • MD Clinical

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Mayo Clinic College of Medicine

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Neurology Associates

    Maitland, Florida 32751
    United States

    Site Not Available

  • Melbourne Internal Medicine Associates, MIMA

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Allied Clinical Trials, Inc.

    Miami, Florida 33156
    United States

    Site Not Available

  • Miami Jewish Health Systems

    Miami, Florida 33137
    United States

    Site Not Available

  • Pharmax Research Clinic, LLC

    Miami, Florida 33126
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • Compass Research, LLC

    Orlando, Florida 32806
    United States

    Site Not Available

  • Palm Beach Neurological Center/Advanced Research Consultants

    Palm Beach Gardens, Florida 33418
    United States

    Site Not Available

  • Neurostudies, Inc

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • The Roskamp Institute, Inc

    Sarasota, Florida 34243
    United States

    Site Not Available

  • Miami Research Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • Suncoast Neuroscience Associates, Inc.

    St Petersburg, Florida 33713
    United States

    Site Not Available

  • Meridien Research

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • Axiom Clinical Research of Florida

    Tampa, Florida 33609
    United States

    Site Not Available

  • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute

    Tampa, Florida 33613
    United States

    Site Not Available

  • Stedman Clinical Trials, LLC

    Tampa, Florida 33613
    United States

    Site Not Available

  • University of South Florida Suncoast Alzheimer's and Gerontology Center

    Tampa, Florida 33613
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Emory University, School of Medicine

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Multiple Sclerosis Center of Atlanta

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • NeuroTrials Research, Inc.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Medical Research and Health Educational Foundation, Inc

    Columbus, Georgia 31909
    United States

    Site Not Available

  • DeKalb Neurology Associates, LLC

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Gwinnett Medical Center

    Lawrenceville, Georgia 30045
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Alexian Brothers Neurosciences Institute

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • Southern Illinois University, School of Medicine

    Springfield, Illinois 62794
    United States

    Site Not Available

  • Elkhart Clinic, LLC

    Elkhart, Indiana 46514
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Mid America Neuroscience Institute

    Lenexa, Kansas 66214
    United States

    Site Not Available

  • Associates in Neurology, PSC

    Lexington, Kentucky 40513
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Associates in Neurology, PSC

    Lexington,, Kentucky 40513
    United States

    Site Not Available

  • Four Rivers Clinical Research, Inc

    Paducah, Kentucky 42003
    United States

    Site Not Available

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana 70629
    United States

    Site Not Available

  • J. Gary Booker, MD, APMC

    Shreveport, Louisiana 71104
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana 70112
    United States

    Site Not Available

  • Maine Medical Partners Neurology

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • McLean Hospital

    Belmont, Massachusetts 02478
    United States

    Site Not Available

  • Boston University School of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • ActivMed Practices and Research, Inc

    Haverhill, Massachusetts 01830
    United States

    Site Not Available

  • Neurocare, Inc

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • Neuroscience Research of the Berkshires

    Pittsfield, Massachusetts 01201
    United States

    Site Not Available

  • Donald S. Marks, MD, P.C.

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • Springfield Neurology Associates

    Springfield, Massachusetts 01104
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Saint Mary's Health Care

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Borgess Medical Center/Borgess Research Institute

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Saint Luke's Hospital, Mid America Brain and Stroke Institute

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • The Center for Pharmaceutical Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • St. Louis University School of Medicine

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63108
    United States

    Site Not Available

  • Deaconess Billings Clinical Research Center

    Billings, Montana 59101
    United States

    Site Not Available

  • Advanced Neurology Specialists

    Great Falls, Montana 59405
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198-2045
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey 07724
    United States

    Site Not Available

  • The Memory Enhancement Center of America, Inc.

    Long Branch, New Jersey 07724
    United States

    Site Not Available

  • Alzheimer's Research Corporation (ARC)

    Manchester, New Jersey 08759
    United States

    Site Not Available

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey 07856
    United States

    Site Not Available

  • Princeton Medical Institute

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • University of Medicine and Dentistry of New Jersey

    Stratford, New Jersey 08084
    United States

    Site Not Available

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Neurological Associates Albany PC

    Albany, New York 12208
    United States

    Site Not Available

  • Neuroscience Research Center at Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Upstate Clinical Research, LLC

    Albany, New York 12205
    United States

    Site Not Available

  • Five Towns Neuroscience Research

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Advanced BioBehavioral Sciences

    Elmsford, New York 10523
    United States

    Site Not Available

  • Empire Neurology, PC

    Latham, New York 12110
    United States

    Site Not Available

  • Neurological Care of CNY

    Liverpool, New York 13088
    United States

    Site Not Available

  • Parker Jewish Institute for Health Care & Rehabilitation

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Mt. Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • NYU School of Medicine/Psychiatry

    New York, New York 10016
    United States

    Site Not Available

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York 10962
    United States

    Site Not Available

  • University of Rochester Medical Center @ Monroe Community Hospital

    Rochester, New York 14620
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Clinical Trials of America, Inc

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • New Hope Clinical Research

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Raleigh Neurology Associates

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research, Inc

    Canton, Ohio 44718
    United States

    Site Not Available

  • NeuroCare Center, Inc

    Canton, Ohio 44718
    United States

    Site Not Available

  • University Memory and Aging Center University Hospitals of Cleveland Case Medical Center

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Neurology Specialists, Inc.

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Red River Medical Research Center, LLC

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Providence Medical Group-Medford Neurology

    Medford, Oregon 97504
    United States

    Site Not Available

  • Oregon Health & Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Providence Health Service System, AD Center, Brain Institute

    Portland, Oregon 97225
    United States

    Site Not Available

  • Summit Research Group, LLC

    Portland, Oregon 97210
    United States

    Site Not Available

  • Abington Neurological Assoc

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Jefferson Hospital for Neuroscience

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Penn Memory Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania 15206
    United States

    Site Not Available

  • University of Virginia

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Universtiy of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Rhode Island Mood and Memory Research Institute

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Medical University of South Carolina

    N. Charleston, South Carolina 29406
    United States

    Site Not Available

  • Avera Research Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Neurology Clinic, PC

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Psychiatric Consultants, PC

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • East Tennessee State University

    Johnson City, Tennessee 37614-1707
    United States

    Site Not Available

  • Volunteer Research Group

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • University of Tennessee Health Science Center

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Psychiatric Consultants, PC

    Nashville, Tennessee 37067
    United States

    Site Not Available

  • Texas Neurology, PA

    Dallas, Texas 75214
    United States

    Site Not Available

  • University of North Texas/Health Sciences Center-Fort Worth

    Fort Worth, Texas 76106
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Innovative Clinical Trials

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Integra Clinical Research, LLC

    San Antonio, Texas 78231
    United States

    Site Not Available

  • University of Utah, Dept. of Neurology

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • The Memory Clinic

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Fletcher Allen Health Care

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Innovative Clinical Research Center

    Alexandria, Virginia 22304
    United States

    Site Not Available

  • Alliance Research Group, LLC

    Richmond, Virginia 23230
    United States

    Site Not Available

  • Pacific Medical Centers

    Seattle, Washington 98144
    United States

    Site Not Available

  • University of Washington Veterans Affairs

    Seattle, Washington 98108
    United States

    Site Not Available

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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