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

NCT00937352 | Terminated Phase 3

• 1 other identifier: ELN115727-351
• Study Type: interventional
• Target: 896
• Locations: 3 countries
• Sites: 191

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Mild to moderate Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Bapineuzumab 0.5 mg/kg

ACTIVE COMPARATOR

0.5 mg/kg

Drug: Bapineuzumab

Bapineuzumab 1.0 mg/kg

ACTIVE COMPARATOR

1.0 mg/kg

Drug: Bapineuzumab

Interventions

Bapineuzumab DRUG

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.

Bapineuzumab 0.5 mg/kg; Bapineuzumab 1.0 mg/kg

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• JANSSEN Alzheimer Immunotherapy Research & Development, LLC: lead
• Pfizer: collaborator

Study Sites (191)

University of Alabama Hospital

Birmingham, Alabama, 35205, United States

Location

Dedicated Clinical Research, Inc.

Goodyear, Arizona, 85395, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

HOPE Research Institute, LLC

Phoenix, Arizona, 85050, United States

Location

Banner Research Institute

Sun City, Arizona, 85351, United States

Location

University of Arizona College of Medicine, Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Northwest NeuroSpecialists, PLLC

Tucson, Arizona, 85741, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

East Bay Physicians Medical Group

Berkeley, California, 94705, United States

Location

AVI Clinical Research

Carson, California, 90746, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Margolin Brain Institute

Fresno, California, 93720, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

Coordinated Clinical Research

La Jolla, California, 92037, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Senior Clinical Trials, Inc.

Laguna Hills, California, 92653, United States

Location

Collaborative NeuroScience Network, Inc.

Long Beach, California, 90806, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

UCLA Department of Neurology

Los Angeles, California, 90095, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Neurology Center

Oceanside, California, 92056, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Neuro-Therapeutics, Inc.

Pasadena, California, 91105, United States

Location

Sutter Neuroscience Medical Group

Sacramento, California, 95816, United States

Location

University of California at Davis, Alzheimer's Disease Research Center

Sacramento, California, 95817, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

Sharp Mesa Vista Hospital

San Diego, California, 92123, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Schuster Medical Research Institute

Sherman Oaks, California, 91403, United States

Location

Diablo Clinical Research, Inc

Walnut Creek, California, 94596, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80304, United States

Location

Mile High Research Center

Denver, Colorado, 80218, United States

Location

Advanced Neurosciences Research, LLC

Fort Collins, Colorado, 80528, United States

Location

Associated Neurologists, PC

Danbury, Connecticut, 06810, United States

Location

Associated Neurologists of Southern Connecticut, P.C.

Fairfield, Connecticut, 06824, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, 06851, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Christiana Care Neurology Specialists

Newark, Delaware, 19713, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

JEM Research, LLC

Atlantis, Florida, 33462, United States

Location

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

Location

Quantum Laboratories, Inc.

Deerfield Beach, Florida, 33064, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neurologic Consultants, PA

Fort Lauderdale, Florida, 33308, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Clinical Physiology Associates, Inc

Fort Myers, Florida, 33916, United States

Location

Emerald Coast Mood and Memory, PA.

Fort Walton Beach, Florida, 32547, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Mayo Clinic College of Medicine

Jacksonville, Florida, 32224, United States

Location

Neurology Associates

Maitland, Florida, 32751, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Pharmax Research Clinic, LLC

Miami, Florida, 33126, United States

Location

Miami Jewish Health Systems

Miami, Florida, 33137, United States

Location

Allied Clinical Trials Inc.

Miami, Florida, 33156, United States

Location

Miami Research Associates

Miami, Florida, 33173, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Palm Beach Neurological Center, Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, 33418, United States

Location

Neurostudies, Inc.

Port Charlotte, Florida, 33952, United States

Location

The Roskamp Institute, Inc

Sarasota, Florida, 34243, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

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

Tampa, Florida, 33613, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, 33613, United States

Location

University of South Florida Suncoast Alzheimer's and Gerontology Center

Tampa, Florida, 33613, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Emory University, School of Medicine

Atlanta, Georgia, 30322, United States

Location

Multiple Sclerosis Center of Atlanta

Atlanta, Georgia, 30327, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Medical Research and Health Education Foundation, Inc.

Columbus, Georgia, 31909, United States

Location

Medical Research and Health Education Foundation, Inc

Columbus, Georgia, 31909, United States

Location

DeKalb Neurology Associates, LLC

Decatur, Georgia, 30033, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Alexian Brothers Neuroscience Institute

Elk Grove Village, Illinois, 60007, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61602, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MidAmerica Neuroscience Institute

Lenexa, Kansas, 66214, United States

Location

Associates in Neurology, PSC

Lexington, Kentucky, 40513, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Four Rivers Clinical Research, Inc.

Paducah, Kentucky, 42003, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

J. Gary Booker, MD, APMC

Shreveport, Louisiana, 71104, United States

Location

Maine Medical Partners Neurology

Scarborough, Maine, 04074, United States

Location

CBH Health, LLC

Rockville, Maryland, 20850, United States

Location

Brigham and Women's Hospital, Dept. of Neurology

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

ActivMed Practices and Research, Inc.

Haverhill, Massachusetts, 01830, United States

Location

Neurocare, Inc.

Newton, Massachusetts, 02459, United States

Location

Neuroscience Research of the Berkshires

Pittsfield, Massachusetts, 01201, United States

Location

Donald S. Marks, MD, PC

Plymouth, Massachusetts, 02360, United States

Location

Springfield Neurology Associates, LLC

Springfield, Massachusetts, 01104, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48105, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Borgess Medical Center/Borgess Research Institute

Kalamazoo, Michigan, 49048, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Washington University School of Medicine

Saint Lous, Missouri, 63108, United States

Location

Saint Louis University School of Medicine

St Louis, Missouri, 63104, United States

Location

Deaconess Billings Clinical Research Center

Billings, Montana, 59101, United States

Location

Advanced Neurology Specialists

Great Falls, Montana, 59405, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, 07724, United States

Location

Alzheimer's Research Corporation

Paterson, New Jersey, 08759, United States

Location

Global Medical Institutes, LLC

Princeton, New Jersey, 08540, United States

Location

Shore Neurology, PA

Toms River, New Jersey, 08755, United States

Location

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, 87109, United States

Location

Upstate Clinical Research, LLC

Albany, New York, 12205, United States

Location

Neurological Associates of Albany, PC

Albany, New York, 12208, United States

Location

Neuroscience Research Center at Albany Medical Center

Albany, New York, 12208, United States

Location

Advanced BioBehavioral Sciences

Elmsford, New York, 10523, United States

Location

Empire Neurology, PC

Latham, New York, 12110, United States

Location

Neurological Care of Central New York

Liverpool, New York, 13088, United States

Location

Parker Jewish Institute for Health Care and Rehabilitation

New Hyde Park, New York, 11040, United States

Location

New York University School of Medicine/Psychiarty

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Nathan S. Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

University of Rochester Medical Center, Monroe Community Hospital

Rochester, New York, 14620, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Clinical Trials of America, Inc

Hickory, North Carolina, 28601, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

Ohio State University, Dept. of Neurology

Columbus, Ohio, 43210, United States

Location

Neurology Specialists, Inc.

Dayton, Ohio, 45417, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Red River Medical Research Center, LLC

Oklahoma City, Oklahoma, 73112, United States

Location

Providence Medical Group-Medford Neurology

Medford, Oregon, 97504, United States

Location

Summit Research Group, LLC

Portland, Oregon, 97223, United States

Location

Providence Health Service System, AD Center, Brain Institute

Portland, Oregon, 97225, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Abington Neurological Associates, Ltd.

Abington, Pennsylvania, 19001, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Penn Memory Center

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Hospital for Neuroscience

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Psychiatric Consultants, PC

Nashville, Tennessee, 37203, United States

Location

Senior Adults Specialty Research (SASR)

Austin, Texas, 78757, United States

Location

Texas Neurology, PA

Dallas, Texas, 75214, United States

Location

University of Texas Southwestern Medical Center, Dept. of Neurology

Dallas, Texas, 75390, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

University of North Texas Health Science Center at Fort Worth

Fort Worth, Texas, 76106, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

Integra Clinical Research, LLC

San Antonio, Texas, 78231, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

University of Utah, Dept. of Neurology

Salt Lake City, Utah, 84108, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Innovative Clinical Research Center

Alexandria, Virginia, 22304, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Alliance Research Group, LLC

Richmond, Virginia, 23230, United States

Location

University of Washington Veterans Affairs

Seattle, Washington, 98108, United States

Location

Pacific Medical Centers

Seattle, Washington, 98144, United States

Location

Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Independent Psychiatric Consultants

Waukesha, Wisconsin, 53188, United States

Location

Landeskrankenhaus- Universitätsklinikum Graz

Graz, Styria, 8036, Austria

Location

University of Calgary, Foothills Medical Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

Medical Arts Health Research Group

Kamloops, British Columbia, V2C 1K7, Canada

Location

Medical Arts Health Research Group

Kelowna, British Columbia, V1Y 3G8, Canada

Location

Queens University Memorial Clinics

Kingston, Ontario, K7L 5G2, Canada

Location

Parkwood Hospital

London, Ontario, N6C 5J1, Canada

Location

Bruyere Continuing Care

Ottawa, Ontario, K1N 5C8, Canada

Location

Neurology Research Inc

Toronto, Ontario, M3B 2S7, Canada

Location

Toronto Centre for Memory and Aging

Toronto, Ontario, M6M 3Z5, Canada

Location

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, L1N 5S9, Canada

Location

Neuro Rive-Sud Memory Clinic

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Sir Mortimer B. Davis, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Douglas Mental Health University Institute

Verdun, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

bapineuzumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 13, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 20, 2013

Record last verified: 2013-11

Locations

CA (14); AU (1); US (176)