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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Bapineuzumab

• Study Type: Interventional
• Enrollment (Actual): 896
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Landeskrankenhaus- Universitätsklinikum Graz
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary, Foothills Medical Centre
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C 1K7
      • Medical Arts Health Research Group
    • Kelowna, British Columbia, Canada, V1Y 3G8
      • Medical Arts Health Research Group
  • Ontario
    • Kingston, Ontario, Canada, K7L 5G2
      • Queens University Memorial Clinics
    • London, Ontario, Canada, N6C 5J1
      • Parkwood Hospital
    • Ottawa, Ontario, Canada, K1N 5C8
      • Bruyere Continuing Care
    • Toronto, Ontario, Canada, M3B 2S7
      • Neurology Research Inc
    • Toronto, Ontario, Canada, M6M 3Z5
      • Toronto Centre for Memory and Aging
    • Whitby, Ontario, Canada, L1N 5S9
      • Ontario Shores Centre for Mental Health Sciences
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Neuro Rive-Sud Memory Clinic
    • Montréal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont
    • Montréal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B. Davis, Jewish General Hospital
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
    • Verdun, Quebec, Canada, H4H 1R3
      • Douglas Mental Health University Institute
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • University of Alabama Hospital
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research, Inc.
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Phoenix, Arizona, United States, 85050
      • HOPE Research Institute, LLC
    • Sun City, Arizona, United States, 85351
      • Banner Research Institute
    • Tucson, Arizona, United States, 85724
      • University of Arizona College of Medicine, Health Sciences Center
    • Tucson, Arizona, United States, 85741
      • Northwest NeuroSpecialists, PLLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials, Inc.
  • California
    • Berkeley, California, United States, 94705
      • East Bay Physicians Medical Group
    • Carson, California, United States, 90746
      • AVI Clinical Research
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc.
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Fresno, California, United States, 93720
      • Margolin Brain Institute
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • La Jolla, California, United States, 92037
      • Coordinated Clinical Research
    • Laguna Hills, California, United States, 92653
      • Senior Clinical Trials, Inc.
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, Inc.
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Los Angeles, California, United States, 90095
      • UCLA Department of Neurology
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • Oceanside, California, United States, 92056
      • Neurology Center
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
    • Pasadena, California, United States, 91105
      • Neuro-Therapeutics, Inc.
    • Sacramento, California, United States, 95816
      • Sutter Neuroscience Medical Group
    • Sacramento, California, United States, 95817
      • University of California at Davis, Alzheimer's Disease Research Center
    • San Diego, California, United States, 92123
      • Sharp Mesa Vista Hospital
    • San Diego, California, United States, 92123
      • Artemis Institute for Clinical Research
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • San Francisco, California, United States, 94109
      • San Francisco Clinical Research Center
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Sherman Oaks, California, United States, 91403
      • Schuster Medical Research Institute
    • Walnut Creek, California, United States, 94596
      • Diablo Clinical Research, Inc
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Alpine Clinical Research Center
    • Denver, Colorado, United States, 80218
      • Mile High Research Center
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research, LLC
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Associated Neurologists, PC
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut, P.C.
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc.
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Neurology Specialists
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University Medical Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research, LLC
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Inc.
    • Deerfield Beach, Florida, United States, 33064
      • Quantum Laboratories, Inc.
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Fort Lauderdale, Florida, United States, 33308
      • Neurologic Consultants, PA
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Fort Myers, Florida, United States, 33916
      • Clinical Physiology Associates, Inc
    • Fort Walton Beach, Florida, United States, 32547
      • Emerald Coast Mood and Memory, PA.
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic College of Medicine
    • Maitland, Florida, United States, 32751
      • Neurology Associates
    • Melbourne, Florida, United States, 32901
      • Melbourne Internal Medicine Associates
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Miami, Florida, United States, 33173
      • Miami Research Associates
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic, LLC
    • Miami, Florida, United States, 33156
      • Allied Clinical Trials Inc.
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Palm Beach Gardens, Florida, United States, 33418
      • Palm Beach Neurological Center, Advanced Research Consultants, Inc.
    • Port Charlotte, Florida, United States, 33952
      • Neurostudies, Inc.
    • Saint Petersburg, Florida, United States, 33713
      • Suncoast Neuroscience Associates, Inc.
    • Sarasota, Florida, United States, 34243
      • The Roskamp Institute, Inc
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States, 33613
      • 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
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research, Inc.
    • Atlanta, Georgia, United States, 30322
      • Emory University, School of Medicine
    • Atlanta, Georgia, United States, 30327
      • Multiple Sclerosis Center of Atlanta
    • Columbus, Georgia, United States, 31909
      • Medical Research and Health Education Foundation, Inc.
    • Columbus, Georgia, United States, 31909
      • Medical Research and Health Education Foundation, Inc
    • Decatur, Georgia, United States, 30033
      • Dekalb Neurology Associates, LLC
    • Lawrenceville, Georgia, United States, 30045
      • Gwinnett Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Neuroscience Institute
    • Peoria, Illinois, United States, 61602
      • Methodist Medical Center of Illinois
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University School of Medicine
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Elkhart Clinic, LLC
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
    • Lenexa, Kansas, United States, 66214
      • MidAmerica Neuroscience Institute
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40513
      • Associates in Neurology, PSC
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research, Inc.
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
    • Shreveport, Louisiana, United States, 71104
      • J. Gary Booker, MD, APMC
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners Neurology
  • Maryland
    • Rockville, Maryland, United States, 20850
      • CBH Health, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Medicine
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital, Dept. of Neurology
    • Haverhill, Massachusetts, United States, 01830
      • ActivMed Practices and Research, Inc.
    • Newton, Massachusetts, United States, 02459
      • Neurocare, Inc.
    • Pittsfield, Massachusetts, United States, 01201
      • Neuroscience Research of the Berkshires
    • Plymouth, Massachusetts, United States, 02360
      • Donald S. Marks, MD, PC
    • Springfield, Massachusetts, United States, 01104
      • Springfield Neurology Associates, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Medical Center/Borgess Research Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University School of Medicine
    • Saint Lous, Missouri, United States, 63108
      • Washington University School of Medicine
  • Montana
    • Billings, Montana, United States, 59101
      • Deaconess Billings Clinical Research Center
    • Great Falls, Montana, United States, 59405
      • Advanced Neurology Specialists
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Memory Enhancement Center of America, Inc.
    • Manchester, New Jersey, United States, 08759
      • Alzheimer's Research Corporation
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institutes, LLC
    • Toms River, New Jersey, United States, 08755
      • Shore Neurology, PA
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience, Inc.
  • New York
    • Albany, New York, United States, 12205
      • Upstate Clinical Research, LLC
    • Albany, New York, United States, 12208
      • Neurological Associates of Albany, PC
    • Albany, New York, United States, 12208
      • Neuroscience Research Center at Albany Medical Center
    • Elmsford, New York, United States, 10523
      • Advanced BioBehavioral Sciences
    • Latham, New York, United States, 12110
      • Empire Neurology, PC
    • Liverpool, New York, United States, 13088
      • Neurological Care of Central New York
    • New Hyde Park, New York, United States, 11040
      • Parker Jewish Institute for Health Care and Rehabilitation
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • New York University School of Medicine/Psychiarty
    • Orangeburg, New York, United States, 10962
      • Nathan S. Kline Institute for Psychiatric Research
    • Rochester, New York, United States, 14620
      • University of Rochester Medical Center, Monroe Community Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America, Inc
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research, Inc.
    • Columbus, Ohio, United States, 43210
      • Ohio State University, Dept. of Neurology
    • Dayton, Ohio, United States, 45417
      • Neurology Specialists, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73112
      • Red River Medical Research Center, LLC
  • Oregon
    • Medford, Oregon, United States, 97504
      • Providence Medical Group-Medford Neurology
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97223
      • Summit Research Group, LLC
    • Portland, Oregon, United States, 97225
      • Providence Health Service System, AD Center, Brain Institute
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates, Ltd.
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Memory Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Hospital For Neuroscience
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15206
      • Clinical Trials Research Services, LLC
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island mood and memory research institute
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Medical University of South Carolina
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Research Institute
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic, P.C.
    • Johnson City, Tennessee, United States, 37614
      • East Tennessee State University
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
    • Nashville, Tennessee, United States, 37203
      • Psychiatric Consultants, PC
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research (Sasr)
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center, Dept. of Neurology
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
    • Fort Worth, Texas, United States, 76106
      • University of North Texas Health Science Center at Fort Worth
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
    • San Antonio, Texas, United States, 78231
      • Integra Clinical Research, Llc
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
    • Salt Lake City, Utah, United States, 84108
      • University of Utah, Dept. of Neurology
  • Vermont
    • Bennington, Vermont, United States, 05201
      • The Memory Clinic
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Innovative Clinical Research Center
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Richmond, Virginia, United States, 23230
      • Alliance Research Group, LLC
  • Washington
    • Seattle, Washington, United States, 98108
      • University of Washington Veterans Affairs
    • Seattle, Washington, United States, 98144
      • Pacific Medical Centers
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
    • Waukesha, Wisconsin, United States, 53188
      • Independent Psychiatric Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.	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

Collaborators and Investigators

• Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): December 20, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Mild to moderate Alzheimer's disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ELN115727-351