A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00937352
First received: July 7, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.


Condition Intervention Phase
Alzheimer's Disease
Drug: Bapineuzumab
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 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments. [ Time Frame: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD. [ Time Frame: The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first ] [ Designated as safety issue: No ]

Enrollment: 896
Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bapineuzumab 0.5 mg/kg
0.5 mg/kg
Drug: Bapineuzumab

0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

Active Comparator: Bapineuzumab 1.0 mg/kg
1.0 mg/kg
Drug: Bapineuzumab

0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.


  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD
  • Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
  • Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
  • Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
  • Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)
  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: NCT00937352

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Hospital
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
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 at Davis, Alzheimer's Disease Research Center
Sacramento, California, United States, 95817
Sutter Neuroscience Medical Group
Sacramento, California, United States, 95816
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
University of California San Francisco
San Francisco, California, United States, 94143
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
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, 94596
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 Connecticut, 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 Neurology Specialists
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, PA
Fort Lauderdale, Florida, United States, 33308
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Clinical Physiology Associates, Inc
Fort Myers, Florida, United States, 33916
Emerald Coast Mood and Memory, PA.
Fort Walton Beach, Florida, United States, 32547
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
Melbourne, Florida, United States, 32901
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Allied Clinical Trials Inc.
Miami, Florida, United States, 33156
Pharmax Research Clinic, LLC
Miami, Florida, United States, 33126
Miami Research Associates
Miami, Florida, United States, 33173
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, LLC
Orlando, Florida, United States, 32806
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States, 33418
Neurostudies, Inc.
Port Charlotte, Florida, United States, 33952
Suncoast Neuroscience Associates, Inc.
Saint Petersburg, Florida, United States, 33713
The Roskamp Institute, Inc
Sarasota, Florida, United States, 34243
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
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
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
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 Education Foundation, Inc.
Columbus, Georgia, United States, 31909
Medical Research and Health Education 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 Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61602
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
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Kentucky
Associates in Neurology, PSC
Lexington, Kentucky, United States, 40513
University of Kentucky
Lexington, Kentucky, United States, 40536
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
United States, Maine
Maine Medical Partners Neurology
Scarborough, Maine, United States, 04074
United States, Maryland
CBH Health, LLC
Rockville, Maryland, United States, 20850
United States, Massachusetts
Brigham and Women's Hospital, Dept. of Neurology
Boston, Massachusetts, United States, 02115
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
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, PC
Plymouth, Massachusetts, United States, 02360
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States, 01104
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48105
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Michigan State University
East Lansing, Michigan, United States, 48824
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
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Saint Louis University School of Medicine
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Lous, 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
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Alzheimer's Research Corporation
Manchester, New Jersey, United States, 08759
Global Medical Institutes, LLC
Princeton, New Jersey, United States, 08540
Shore Neurology, PA
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States, 87109
United States, New York
Neuroscience Research Center at Albany Medical Center
Albany, New York, United States, 12208
Neurological Associates of Albany, PC
Albany, New York, United States, 12208
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
Advanced BioBehavioral Sciences
Elmsford, New York, United States, 10523
Empire Neurology, PC
Latham, New York, United States, 12110
Neurological Care of Central New York
Liverpool, New York, United States, 13088
Parker Jewish Institute for Health Care and Rehabilitation
New Hyde Park, New York, United States, 11040
Columbia University Medical Center
New York, New York, United States, 10032
New York University School of Medicine/Psychiarty
New York, New York, United States, 10016
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
Clinical Trials of America, Inc
Hickory, North Carolina, United States, 28601
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States, 44718
Ohio State University, Dept. of Neurology
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
Oregon Health and Science University
Portland, Oregon, United States, 97239
Summit Research Group, LLC
Portland, Oregon, United States, 97223
Providence Health Service System, AD Center, Brain Institute
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Neurological Associates, Ltd.
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
Penn Memory Center
Philadelphia, Pennsylvania, United States, 19104
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States, 15206
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
North 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, P.C.
Cordova, Tennessee, United States, 38018
East Tennessee State University
Johnson City, Tennessee, United States, 37614
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
Psychiatric Consultants, PC
Nashville, Tennessee, United States, 37203
United States, Texas
Senior Adults Specialty Research (SASR)
Austin, Texas, United States, 78757
University of Texas Southwestern Medical Center, Dept. of Neurology
Dallas, Texas, United States, 75390
Texas Neurology, PA
Dallas, Texas, United States, 75214
InSite Clinical Research
DeSoto, Texas, United States, 75115
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, United States, 76106
Baylor College of Medicine
Houston, Texas, United States, 77030
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78231
United States, Utah
University of Utah, Dept. of Neurology
Salt Lake City, Utah, United States, 84108
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
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
University of Virginia
Charlottesville, Virginia, United States, 22903
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
Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States, 53188
Austria
Landeskrankenhaus- Universitätsklinikum Graz
Graz, Styria, Austria, 8036
Canada, Alberta
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Medical Arts Health Research Group
Kamloops, British Columbia, Canada, V2C 1K7
Medical Arts Health Research Group
Kelowna, British Columbia, Canada, V1Y 3G8
Canada, Ontario
Queens University Memorial Clinics
Kingston, Ontario, Canada, K7L 5G2
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Toronto Centre for Memory and Aging
Toronto, Ontario, Canada, M6M 3Z5
Neurology Research Inc
Toronto, Ontario, Canada, M3B 2S7
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, Canada, L1N 5S9
Canada, Quebec
Neuro Rive-Sud Memory Clinic
Greenfield Park, Quebec, Canada, J4V 2J2
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Sir Mortimer B. Davis, Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Douglas Mental Health University Institute
Verdun, Quebec, Canada, H4H 1R3
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00937352     History of Changes
Other Study ID Numbers: ELN115727-351
Study First Received: July 7, 2009
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Austria: Austrian Agency for Health and Food Safety (AGES)
Germany: Paul-Ehrlich-Institut (PEI)

Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
Mild to moderate Alzheimer's disease

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 October 01, 2014