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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00575055
First received: December 10, 2007
Last updated: October 30, 2013
Last verified: October 2013
  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 0.5 mg/kg
Drug: Placebo Control
Drug: Bapineuzumab 1.0 m/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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 ]
  • Imaging and biochemical biomarkers of disease status [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 1121
Study Start Date: December 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bapineuzumab 0.5 mg/kg
infusion every 13 weeks for a total of 6 infusions
Drug: Bapineuzumab 0.5 mg/kg
given by infusion every 13 weeks for a total of 6 infusions.
Other Name: AAB-001
Placebo Comparator: Placebo Dose
infusion every 13 weeks for a total of 6 infusions.
Drug: Placebo Control
given by infusion every 13 weeks for a total of 6 infusions.
Experimental: Bapineuzumab 1.0 m/kg
infusion every 13 weeks for a total of 6 infusions.
Drug: Bapineuzumab 1.0 m/kg
given by infusion every 13 weeks for a total of 6 infusions.
Other Name: AAB-001

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575055

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Hospital (UAB)
Birmingham, Alabama, United States, 35205
United States, Arizona
Dedicated Clinical Research, Inc.
Goodyear, Arizona, United States, 85395
HOPE Research Institute, LLC
Phoenix, Arizona, United States, 85050
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Banner Research Institute
Sun City, Arizona, United States, 85351
University of Arizona College of Medicine, Health Sciences Center
Tucson, Arizona, United States, 85724
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States, 85741
United States, Arkansas
Clinical Trials Inc.
Little Rock, Arkansas, United States, 72205
United States, California
East Bay Physicians Medical Group
Berkeley, California, United States, 94705
AVI Clinical Research
Carson, California, United States, 90746
ATP Clinical Research, Inc
Costa Mesa, California, United States, 92626
Pharmacology Research Institute
Encino, California, United States, 91316
Margolin Brain Institute
Fresno, California, United States, 93720
Neurology Center of North Orange County
Fullerton, California, United States, 92835
University of California San Diego
La Jolla, California, United States, 92037
Coordinated Clinical Research
La Jolla, California, United States, 92037
Senior Clinical Trials, Inc
Laguna Hills, California, United States, 92653
Collaborative NeuroScience Network, Inc.
Long Beach, California, United States, 90806
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
UCLA Department of Neurology
Los Angeles, California, United States, 90095
Vintage Institute for Clinical Research, Inc
Los Angeles, California, United States, 90035
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Neurology Center
Oceanside, California, United States, 92056
University of California Irvine Medical Center
Orange, California, United States, 92868
Neuro-Therapeutics Inc.
Pasadena, California, United States, 91105
University of California Davis Alzheimer's Disease Research Center
Sacramento, California, United States, 95817
Sutter Neuroscience Medical Group
Sacramento, California, United States, 95816
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
University of California at San Francisco Medical Center at Parnassus
San Francisco, California, United States, 94117
Neurological Research Institute
Santa Monica, California, United States, 90404
Schuster Medical Research Institute
Sherman Oaks, California, United States, 91403
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304
Mile High Research Center
Denver, Colorado, United States, 80218
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Associated Neurologists, PC
Danbury, Connecticut, United States, 06810
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States, 06824
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Research Center for Clinical Studies, Inc
Norwalk, Connecticut, United States, 06851
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
United States, Florida
JEM Research, LLC
Atlantis, Florida, United States, 33462
Bradenton Research Center, Inc
Bradenton, Florida, United States, 34205
Quantum Laboratories, Inc.
Deerfield Beach, Florida, United States, 33064
Brain Matters Research
Delray Beach, Florida, United States, 33445
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, United States, 33308
Clinical Physiology Associates, Inc.
Fort Myers, Florida, United States, 33916
Emerald Coast Mood & Memory, PA.
Fort Walton Beach, Florida, United States, 32547
Neuropsychiatric Research Center of Southwest Florida
Ft. Myers, Florida, United States, 33912
MD Clinical
Hallandale Beach, Florida, United States, 33009
Mayo Clinic College of Medicine
Jacksonville, Florida, United States, 32224
Neurology Associates
Maitland, Florida, United States, 32751
Melbourne Internal Medicine Associates, MIMA
Melbourne, Florida, United States, 32901
Allied Clinical Trials, Inc.
Miami, Florida, United States, 33156
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Pharmax Research Clinic, LLC
Miami, Florida, United States, 33126
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, LLC
Orlando, Florida, United States, 32806
Palm Beach Neurological Center/Advanced Research Consultants
Palm Beach Gardens, Florida, United States, 33418
Neurostudies, Inc
Port Charlotte, Florida, United States, 33952
The Roskamp Institute, Inc
Sarasota, Florida, United States, 34243
Miami Research Associates
South Miami, Florida, United States, 33143
Suncoast Neuroscience Associates, Inc.
St Petersburg, Florida, United States, 33713
Meridien Research
St. Petersburg, Florida, United States, 33709
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
Tampa, Florida, United States, 33613
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, United States, 33613
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, United States, 30327
Emory University, School of Medicine
Atlanta, Georgia, United States, 30322
NeuroTrials Research, Inc.
Atlanta, Georgia, United States, 30342
Medical Research and Health Educational Foundation, Inc
Columbus, Georgia, United States, 31909
DeKalb Neurology Associates, LLC
Decatur, Georgia, United States, 30033
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, United States, 60007
Southern Illinois University, School of Medicine
Springfield, Illinois, United States, 62794
United States, Indiana
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Mid America Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Associates in Neurology, PSC
Lexington, Kentucky, United States, 40513
Four Rivers Clinical Research, Inc
Paducah, Kentucky, United States, 42003
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
J. Gary Booker, MD, APMC
Shreveport, Louisiana, United States, 71104
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 70112
United States, Maine
Maine Medical Partners Neurology
Scarborough, Maine, United States, 04074
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
ActivMed Practices and Research, Inc
Haverhill, Massachusetts, United States, 01830
Neurocare, Inc
Newton, Massachusetts, United States, 02459
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, United States, 01201
Donald S. Marks, MD, P.C.
Plymouth, Massachusetts, United States, 02360
Springfield Neurology Associates
Springfield, Massachusetts, United States, 01104
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Michigan State University
East Lansing, Michigan, United States, 48824
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Borgess Medical Center/Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Saint Luke's Hospital, Mid America Brain and Stroke Institute
Kansas City, Missouri, United States, 64111
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63104
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
United States, Montana
Deaconess Billings Clinical Research Center
Billings, Montana, United States, 59101
Advanced Neurology Specialists
Great Falls, Montana, United States, 59405
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2045
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Alzheimer's Research Corporation (ARC)
Manchester, New Jersey, United States, 08759
The NeuroCognitive Institute
Mount Arlington, New Jersey, United States, 07856
Princeton Medical Institute
Princeton, New Jersey, United States, 08540
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, United States, 08084
United States, New Mexico
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States, 87109
United States, New York
Neurological Associates Albany PC
Albany, New York, United States, 12208
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
Neuroscience Research Center at Albany Medical Center
Albany, New York, United States, 12208
Five Towns Neuroscience Research
Cedarhurst, New York, United States, 11516
Advanced BioBehavioral Sciences
Elmsford, New York, United States, 10523
Empire Neurology, PC
Latham, New York, United States, 12110
Neurological Care of CNY
Liverpool, New York, United States, 13088
Parker Jewish Institute for Health Care & Rehabilitation
New Hyde Park, New York, United States, 11040
NYU School of Medicine/Psychiatry
New York, New York, United States, 10016
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962
University of Rochester Medical Center @ Monroe Community Hospital
Rochester, New York, United States, 14620
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
New Hope Clinical Research
Hickory, North Carolina, United States, 28601
Clinical Trials of America, Inc
Hickory, North Carolina, United States, 28601
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
Beachwood, Ohio, United States, 44122
NeuroCare Center, Inc
Canton, Ohio, United States, 44718
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, United States, 44718
The Ohio State University
Columbus, Ohio, United States, 43210
Neurology Specialists, Inc.
Dayton, Ohio, United States, 45417
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Providence Medical Group-Medford Neurology
Medford, Oregon, United States, 97504
Summit Research Group, LLC
Portland, Oregon, United States, 97210
Providence Health Service System, AD Center, Brain Institute
Portland, Oregon, United States, 97225
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Abington Neurological Assoc
Abington, Pennsylvania, United States, 19001
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States, 19107
Penn Memory Center
Philadelphia, Pennsylvania, United States, 19104
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States, 15206
Universtiy of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
University of Virginia
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States, 02914
Butler Hospital
Providence, Rhode Island, United States, 02906
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
N. Charleston, South Carolina, United States, 29406
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Neurology Clinic, PC
Cordova, Tennessee, United States, 38018
Psychiatric Consultants, PC
Franklin, Tennessee, United States, 37067
East Tennessee State University
Johnson City, Tennessee, United States, 37614-1707
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
United States, Texas
Texas Neurology, PA
Dallas, Texas, United States, 75214
University of North Texas/Health Sciences Center-Fort Worth
Fort Worth, Texas, United States, 76106
Baylor College of Medicine
Houston, Texas, United States, 77030
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78231
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
University of Utah, Dept. of Neurology
Salt Lake City, Utah, United States, 84108
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Innovative Clinical Research Center
Alexandria, Virginia, United States, 22304
Alliance Research Group, LLC
Richmond, Virginia, United States, 23230
United States, Washington
Pacific Medical Centers
Seattle, Washington, United States, 98144
University of Washington Veterans Affairs
Seattle, Washington, United States, 98108
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53705
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

No publications provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00575055     History of Changes
Other Study ID Numbers: ELN115727-302
Study First Received: December 10, 2007
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014