Clinical trial NCT00937352: A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Mild to moderate Alzheimer's disease
Lead sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-07-13
Enrollment: 896
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol
Secondary outcomes:
measure: To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute, LLC
state: Arizona
city: Sun City
country: United States
facility: Banner Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona College of Medicine, Health Sciences Center
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, PLLC
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Berkeley
country: United States
facility: East Bay Physicians Medical Group
state: California
city: Carson
country: United States
facility: AVI Clinical Research
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: La Jolla
country: United States
facility: Coordinated Clinical Research
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Laguna Hills
country: United States
facility: Senior Clinical Trials, Inc.
state: California
city: Long Beach
country: United States
facility: Collaborative NeuroScience Network, Inc.
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: UCLA Department of Neurology
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Oceanside
country: United States
facility: Neurology Center
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics, Inc.
state: California
city: Sacramento
country: United States
facility: Sutter Neuroscience Medical Group
state: California
city: Sacramento
country: United States
facility: University of California at Davis, Alzheimer's Disease Research Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC
state: Colorado
city: Danbury
country: United States
facility: Associated Neurologists, PC
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, P.C.
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Neurology Specialists
state: Delaware
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Atlantis
country: United States
facility: JEM Research, LLC
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Deerfield Beach
country: United States
facility: Quantum Laboratories, Inc.
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Neurologic Consultants, PA
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates, Inc
state: Florida
city: Fort Walton Beach
country: United States
facility: Emerald Coast Mood and Memory, PA.
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic College of Medicine
state: Florida
city: Maitland
country: United States
facility: Neurology Associates
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, LLC
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Miami
country: United States
facility: Allied Clinical Trials Inc.
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center, Advanced Research Consultants, Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Sarasota
country: United States
facility: The Roskamp Institute, Inc
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida Suncoast Alzheimer's and Gerontology Center
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University, School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Multiple Sclerosis Center of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Columbus
country: United States
facility: Medical Research and Health Education Foundation, Inc.
state: Georgia
city: Columbus
country: United States
facility: Medical Research and Health Education Foundation, Inc
state: Georgia
city: Decatur
country: United States
facility: DeKalb Neurology Associates, LLC
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neuroscience Institute
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Lexington
country: United States
facility: Associates in Neurology, PSC
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Shreveport
country: United States
facility: J. Gary Booker, MD, APMC
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Partners Neurology
state: Maine
city: Rockville
country: United States
facility: CBH Health, LLC
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital, Dept. of Neurology
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Haverhill
country: United States
facility: ActivMed Practices and Research, Inc.
state: Massachusetts
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Pittsfield
country: United States
facility: Neuroscience Research of the Berkshires
state: Massachusetts
city: Plymouth
country: United States
facility: Donald S. Marks, MD, PC
state: Massachusetts
city: Springfield
country: United States
facility: Springfield Neurology Associates, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center/Borgess Research Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine
state: Missouri
city: Saint Lous
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinical Research Center
state: Montana
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Manchester
country: United States
facility: Alzheimer's Research Corporation
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes, LLC
state: New Jersey
city: Toms River
country: United States
facility: Shore Neurology, PA
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Albany
country: United States
facility: Neurological Associates of Albany, PC
state: New York
city: Albany
country: United States
facility: Neuroscience Research Center at Albany Medical Center
state: New York
city: Elmsford
country: United States
facility: Advanced BioBehavioral Sciences
state: New York
city: Latham
country: United States
facility: Empire Neurology, PC
state: New York
city: Liverpool
country: United States
facility: Neurological Care of Central New York
state: New York
city: New Hyde Park
country: United States
facility: Parker Jewish Institute for Health Care and Rehabilitation
state: New York
city: New York
country: United States
facility: New York University School of Medicine/Psychiarty
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Orangeburg
country: United States
facility: Nathan S. Kline Institute for Psychiatric Research
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center, Monroe Community Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Ohio State University, Dept. of Neurology
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Red River Medical Research Center, LLC
state: Oklahoma
city: Medford
country: United States
facility: Providence Medical Group-Medford Neurology
state: Oregon
city: Portland
country: United States
facility: Summit Research Group, LLC
state: Oregon
city: Portland
country: United States
facility: Providence Health Service System, AD Center, Brain Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates, Ltd.
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Memory Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Hospital for Neuroscience
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood and Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: North Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Cordova
country: United States
facility: Neurology Clinic, P.C.
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Nashville
country: United States
facility: Psychiatric Consultants, PC
state: Tennessee
city: Austin
country: United States
facility: Senior Adults Specialty Research (SASR)
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Dept. of Neurology
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center at Fort Worth
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah, Dept. of Neurology
state: Utah
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Alexandria
country: United States
facility: Innovative Clinical Research Center
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Alliance Research Group, LLC
state: Virginia
city: Seattle
country: United States
facility: University of Washington Veterans Affairs
state: Washington
city: Seattle
country: United States
facility: Pacific Medical Centers
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: Independent Psychiatric Consultants
state: Wisconsin
city: Graz
country: Austria
facility: Landeskrankenhaus- Universitätsklinikum Graz
state: Styria
city: Calgary
country: Canada
facility: University of Calgary, Foothills Medical Centre
state: Alberta
city: Kamloops
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Kingston
country: Canada
facility: Queens University Memorial Clinics
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Bruyere Continuing Care
state: Ontario
city: Toronto
country: Canada
facility: Neurology Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Toronto Centre for Memory and Aging
state: Ontario
city: Whitby
country: Canada
facility: Ontario Shores Centre for Mental Health Sciences
state: Ontario
city: Greenfield Park
country: Canada
facility: Neuro Rive-Sud Memory Clinic
state: Quebec
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: Sir Mortimer B. Davis, Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Verdun
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
References: