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

Alzheimer's Disease Clinical Trial

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 Non- Carriers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574132
• Other study ID #: ELN115727-301
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2007
• Last updated: October 30, 2013
• Start date: December 2007
• Est. completion date: June 2012

Study information

• Verified date: October 2013
• Source: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustria: Austrian Agency for Health and Food Safety (AGES)Germany: Paul-Ehrlich-Institut (PEI)
• Study type: Interventional

Clinical Trial Summary

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 230 study sites in the US and Canada and up to 35 sites outside of North America 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1331
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 88 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Bapineuzumab 0.5 mg/kg
infusion every 13 weeks for a total of 6 infusions
• Placebo Control
given by infusion every 13 weeks for a total of 6 infusions.
• Bapineuzumab 1.0 m/kg
infusion every 13 weeks for a total of 6 infusions

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz	Styria
Austria	Medizinische Universität Wien	Wien	Vienna
Canada	University of Calgary, Foothills Medical Centre	Calgary	Alberta
Canada	Neuro Rive-Sud Memory Clinic	Greenfield Park	Quebec
Canada	Medical Arts Health Research Group	Kamloops	British Columbia
Canada	Medical Arts Health Research Group	Kelowna	British Columbia
Canada	Hotel Dieu Hospital/Queens University Memorial Clinics	Kingston	Ontario
Canada	Parkwood Hospital	London	Ontario
Canada	Saint Joseph's Health Care London, Saint Joseph's Hospital	London	Ontario
Canada	Hopital Maisonneuve-Rosemont, Comite d' ethique de la recherche	Montreal	Quebec
Canada	Jewish General Hospital	Montréal	Quebec
Canada	Bruyere Continuing Care	Ottawa	Ontario
Canada	Medical Arts Health Research Group	Penticton	British Columbia
Canada	Kawartha Regional Memory Clinic	Peterborough	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Neurology Research Inch./Toronto Memory Program	Toronto	Ontario
Canada	Toronto Centre for Memory and Aging	Toronto	Ontario
Canada	University of British Columbia (UBC) Hospital	Vancouver	British Columbia
Canada	Douglas Mental Health University Institute	Verdun	Quebec
Canada	Ontario Shores Centre for Mental Health Scienes	Whitby	Ontario
Germany	Saint Josefs Hospital	Bochum	Nordrhein-westfalen
Germany	ABX-CRO advanced pharmaceutical services Forschungsgesellschaft GmbH	Dresden	Saschen
Germany	Universitätsklinik Freiburg	Freiburg	Baden-Württemberg
Germany	Universitätsklinikum Ulm	Günzburg	Bayern
Germany	UKE Hamburg	Hamburg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar	Saarland
Germany	AFL Arzneimittelforschung Leipzig GmbH	Leipzig	Sachen
Germany	Klinikum Rechts der Isar der Technischen Universität München	München	Bayern
Germany	Ludwig-Maximilians-Universität München	München	Bayern
Germany	Universitätsklinikum Regensburg	Regensburg	Byern
Germany	Universitätsklinik Tübingen	Tübingen	Baden-wuerttemberg
Germany	Universitätsklinik Ulm	Ulm	Baden-wuerttemberg
United States	Abington Neurological Associates, Ltd	Abington	Pennsylvania
United States	Neurological Associates of Albany, P.C.	Albany	New York
United States	Neuroscience Research Center at Albany Medical Center	Albany	New York
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	University of New Mexico, Health Sciences Center	Albuquerque	New Mexico
United States	Innovative Clinical Research Center	Alexandria	Virginia
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University/School of Medicine	Atlanta	Georgia
United States	MS Center of Atlanta	Atlanta	Georgia
United States	NeuroTrials Research, Inc.	Atlanta	Georgia
United States	JEM Research, LLC	Atlantis	Florida
United States	Senior Adults Specialty Research (SASR)	Austin	Texas
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Rakesh Ranjan, M.D. & Associates, Inc.	Beachwood	Ohio
United States	McLean Hospital	Belmont	Massachusetts
United States	The Memory Clinic	Bennington	Vermont
United States	East Bay Physicians Medical Group	Berkeley	California
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Deaconess Billings Clinical Research Center	Billings	Montana
United States	University of Alabama Hospital (UAB)	Birmingham	Alabama
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Bradenton Research Center, Inc	Bradenton	Florida
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Neuro-Behavioral Clinical Research, Inc	Canton	Ohio
United States	NeuroCare Center, Inc	Canton	Ohio
United States	AVI Clinical Research	Carson	California
United States	Five Towns Neuroscience Research	Cedarhurst	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University Memory and Aging Center University Hospitals of Cleveland/Case Medical Center	Cleveland	Ohio
United States	Medical Research and Health Education Foundation, Inc.	Columbus	Georgia
United States	Ohio State University	Columbus	Ohio
United States	Neurology Clinic, PC	Cordova	Tennessee
United States	ATP Clinical Research, Inc	Costa Mesa	California
United States	Texas Neurology, PA	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Associated Neurologists, PC	Danbury	Connecticut
United States	Neurology Specialists, Inc.	Dayton	Ohio
United States	Dekalb Neurology Associates	Decatur	Georgia
United States	Quantum Laboratories, Inc.	Deerfield Beach	Florida
United States	Brain Matters Research, Inc.	Delray Beach	Florida
United States	Mile High Research Center	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Coastal Neurology, PA	Dover	New Hampshire
United States	Duke University Medical Center	Durham	North Carolina
United States	Michigan State University	East Lansing	Michigan
United States	Rhode Island Mood and Memory Research Institute	East Providence	Rhode Island
United States	The Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Alexian Brothers Neurosciences Institute	Elk Grove Village	Illinois
United States	Elkhart Clinic, LLC	Elkhart	Indiana
United States	Advanced Bio-Behavioral Sciences	Elmsford	New York
United States	Pharmacology Research Institute	Encino	California
United States	Associated Neurologists of Southern CT, P.C.	Fairfield	Connecticut
United States	Precise Research Centers	Flowood	Mississippi
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	Neurologic Consultants, P.A.	Fort Lauderdale	Florida
United States	Clinical Physiology Associates, Inc.	Fort Myers	Florida
United States	Emerald Coast Mood & Memory, PA.	Fort Walton Beach	Florida
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	University of North Texas/Health Sciences Center-Fort Worth	Fort Worth	Texas
United States	Psychiatric Consultants, PC	Franklin	Tennessee
United States	Margolin Brain Institute	Fresno	California
United States	Neuropsychiatric Research Center of Southwest Florida	Ft. Myers	Florida
United States	Neurology Center of North Orange County	Fullerton	California
United States	Integrated Medical and Behavioral Associates	Glendale	California
United States	Dedicated Clinical Research, Inc.	Goodyear	Arizona
United States	Saint Mary's Health Care	Grand Rapids	Michigan
United States	Advanced Neurology Specialists	Great Falls	Montana
United States	MD Clinical	Hallandale Beach	Florida
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	ActivMed Practices and Research, Inc	Haverhill	Massachusetts
United States	Clinical Trials of America, Inc	Hickory	North Carolina
United States	New Hope Clinical Research	Hickory	North Carolina
United States	Sunrise Clinical Research, Inc.	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Claghorn-Lesem Research Clinic, Ltd.	Houston	Texas
United States	Sun Valley Behavioral Medical Center	Imperial	California
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Mayo Clinic College of Medicine	Jacksonville	Florida
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	East Tennessee State University	Johnson City	Tennessee
United States	Borgess Medical Center/Borgess Research Institute	Kalamazoo	Michigan
United States	Kansas Multi-Specialist Group	Kansas City	Kansas
United States	Saint Luke's Hospital, Mid America Brain and Stroke Institute	Kansas City	Missouri
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Coordinated Clinical Research	La Jolla	California
United States	University of California San Diego/Shela Marcos Alzheimer's Disease Research Center	La Jolla	California
United States	Senior Clinical Trials	Laguna Hills	California
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Empire Neurology, PC	Latham	New York
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Dartmouth Hitchcock Medical Center, Dept of Neurology	Lebanon	New Hampshire
United States	Mid America Neuroscience Institute	Lenexa	Kansas
United States	Associates in Neurology, PSC	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Clinical Trials Inc.	Little Rock	Arkansas
United States	Neurological Care of CNY	Liverpool	New York
United States	Collaborative Neuroscience Network	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	UCLA Department of Neurology	Los Angeles	California
United States	Vintage Institute for Clinical Research, Inc	Los Angeles	California
United States	University of Wisconson Medical School of Medicine and Public Health	Madison	Wisconsin
United States	Neurology Associates	Maitland	Florida
United States	Alzheimer's Research Corporation (ARC)	Manchester	New Jersey
United States	Providence Medical Group-Medford Neurology	Medford	Oregon
United States	Melbourne International Medicine Associates, MIMA	Melbourne	Florida
United States	Allied Clinical Trials, Inc.	Miami	Florida
United States	Miami Jewish Health Systems	Miami	Florida
United States	Pharmax Research Clinic, LLC	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	The NeuroCognitive Institute	Mount Arlington	New Jersey
United States	Medical University of South Carolina	N. Charleston	South Carolina
United States	Synergy Research	National City	California
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Yale University School of Medicine, Alzheimer's Disease Research Unit	New Haven	Connecticut
United States	Parker Jewish Institute for Health Care & Rehabilitation	New Hyde Park	New York
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	Columbia University/Medical Center	New York	New York
United States	Dent Neurologic Institute	New York	New York
United States	Mt. Sinai School of Medicine	New York	New York
United States	NYU School of Medicine/Psychiatry	New York	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	Pharmacology Research Institute	Newport Beach	California
United States	Neurocare, Inc.	Newton	Massachusetts
United States	Research Center for Clinical Studies, Inc	Norwalk	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	The Neurology Center	Oceanside	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Red River Medical Research Center, LLC	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California, Irvine Medical Center	Orange	California
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Nathan S. Kline Institute for Psychiatric Research	Orangeburg	New York
United States	Compass Research, LLC	Orlando	Florida
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Palm Beach Neurological Center/Advanced Research Consultants	Palm Beach Gardens	Florida
United States	Neuro-Therapeutics Inc.	Pasadena	California
United States	Broward Research Group, Inc.	Pembroke Pines	Florida
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Jefferson Hospital for Neuroscience	Philadelphia	Pennsylvania
United States	Penn Memory Center	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	HOPE Research Institute, LLC	Phoenix	Arizona
United States	Clinical Trials Research Services, LLC	Pittsburg	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Neuroscience Research of the Berkshires	Pittsfield	Massachusetts
United States	Donald S. Marks, MD, P.C.	Plymouth	Massachusetts
United States	Neurostudies, Inc	Port Charlotte	Florida
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Providence Health Service System, AD Center, Brain Institute	Portland	Oregon
United States	Summit Research Group, Inc.	Portland	Oregon
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Butler Hospital	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	The Southwest Institute for Clinical Research, Inc.	Rancho Mirage	California
United States	Alliance Research Group, LLC	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center @ Monroe Community Hospital	Rochester	New York
United States	CBH Health, LLC	Rockville	Maryland
United States	Sutter Neuroscience Medical Group	Sacramento	California
United States	University of California, Davis, Alzheimer's Disease Center	Sacramento	California
United States	University of Utah, Dept of Neurology	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Innovative Clinical Trials	San Antonio	Texas
United States	Integra Clinical Research, LLC	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Sharp Mesa Vista Hospital	San Diego	California
United States	San Francisco Clinical Research Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Neurological Research Institute	Santa Monica	California
United States	Roskamp Institute	Sarasota	Florida
United States	Maine Medical Partners Neurology	Scarborough	Maine
United States	Pacific Medical Centers	Seattle	Washington
United States	University of Washington Veterans Affairs	Seattle	Washington
United States	Schuster Medical Research Institute	Sherman Oaks	California
United States	J. Gary Booker, MD, APMC	Shreveport	Louisiana
United States	Louisana State University Health Sciences Center	Shreveport	Louisiana
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	Miami Research Associates	South Miami	Florida
United States	Memory Wellness Clinic	Springfield	Massachusetts
United States	Southern Illinois University, School of Medicine	Springfield	Illinois
United States	Springfield Neurology Associates	Springfield	Massachusetts
United States	Suncoast Neuroscience Associates, Inc.	St Petersburg	Florida
United States	St. Louis University School of Medicine	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Meridien Research	St. Petersburg	Florida
United States	University of Medicine and Dentistry of New Jersey	Stratford	New Jersey
United States	Banner Research Institute	Sun City	Arizona
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	University of South Florida Suncoast Alzheimer's and Gerontology Center	Tampa	Florida
United States	Neurology and Neuroscience Center of Ohio	Toledo	Ohio
United States	Shore Neurology, P.A.	Toms River	New Jersey
United States	Northwest Neurospecialists, PLLC	Tucson	Arizona
United States	University of Arizona College of Medicine, Health Science Center	Tucson	Arizona
United States	Diablo Clinical Research, Inc	Walnut Creek	California
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Independent Pyschiatric Consultants	Waukesha	Wisconsin
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Coastal Research Associates, Inc.	Weymouth	Massachusetts
United States	Grayline Clinical Drug Trials, Inc	Wichita Falls	Texas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
JANSSEN Alzheimer Immunotherapy Research & Development, LLC	Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive and Functional		18 months	No
Secondary	Cognitive and Global		18 months	No
Secondary	Imaging and biochemical biomarkers of disease status		18 months	No