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

Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00937352
• Other study ID #: ELN115727-351
• Status: Terminated
• Phase: Phase 3
• First received: July 7, 2009
• Last updated: November 26, 2013
• Start date: July 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 896
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years and older

Eligibility

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 Design

Allocation: Randomized, 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, 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.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus- Universitätsklinikum Graz	Graz	Styria
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	Queens University Memorial Clinics	Kingston	Ontario
Canada	Parkwood Hospital	London	Ontario
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	Sir Mortimer B. Davis, Jewish General Hospital	Montréal	Quebec
Canada	Bruyere Continuing Care	Ottawa	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Neurology Research Inc	Toronto	Ontario
Canada	Toronto Centre for Memory and Aging	Toronto	Ontario
Canada	Douglas Mental Health University Institute	Verdun	Quebec
Canada	Ontario Shores Centre for Mental Health Sciences	Whitby	Ontario
United States	Abington Neurological Associates, Ltd.	Abington	Pennsylvania
United States	Neurological Associates of Albany, PC	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	Innovative Clinical Research Center	Alexandria	Virginia
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Emory University, School of Medicine	Atlanta	Georgia
United States	Multiple Sclerosis 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	The Memory Clinic	Bennington	Vermont
United States	East Bay Physicians Medical Group	Berkeley	California
United States	Deaconess Billings Clinical Research Center	Billings	Montana
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital, Dept. of Neurology	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Bradenton Research Center, Inc.	Bradenton	Florida
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	AVI Clinical Research	Carson	California
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Medical Research and Health Education Foundation, Inc	Columbus	Georgia
United States	Medical Research and Health Education Foundation, Inc.	Columbus	Georgia
United States	Ohio State University, Dept. of Neurology	Columbus	Ohio
United States	Neurology Clinic, P.C.	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, Dept. of Neurology	Dallas	Texas
United States	Associated Neurologists, PC	Danbury	Connecticut
United States	Neurology Specialists, Inc.	Dayton	Ohio
United States	DeKalb Neurology Associates, LLC	Decatur	Georgia
United States	Quantum Laboratories, Inc.	Deerfield Beach	Florida
United States	Brain Matters Research	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	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	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Alexian Brothers Neuroscience Institute	Elk Grove Village	Illinois
United States	Elkhart Clinic, LLC	Elkhart	Indiana
United States	Advanced BioBehavioral Sciences	Elmsford	New York
United States	Pharmacology Research Institute	Encino	California
United States	Associated Neurologists of Southern Connecticut, P.C.	Fairfield	Connecticut
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	Neurologic Consultants, PA	Fort Lauderdale	Florida
United States	Clinical Physiology Associates, Inc	Fort Myers	Florida
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Emerald Coast Mood and Memory, PA.	Fort Walton Beach	Florida
United States	University of North Texas Health Science Center at Fort Worth	Fort Worth	Texas
United States	Margolin Brain Institute	Fresno	California
United States	Neurology Center of North Orange County	Fullerton	California
United States	Dedicated Clinical Research, Inc.	Goodyear	Arizona
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	Baylor College of Medicine	Houston	Texas
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	Center for Pharmaceutical Research	Kansas City	Missouri
United States	The 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	La Jolla	California
United States	Senior Clinical Trials, Inc.	Laguna Hills	California
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Empire Neurology, PC	Latham	New York
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	MidAmerica 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 Central New York	Liverpool	New York
United States	Collaborative NeuroScience Network, Inc.	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	UCLA Department of Neurology	Los Angeles	California
United States	Neurology Associates	Maitland	Florida
United States	Alzheimer's Research Corporation	Manchester	New Jersey
United States	Providence Medical Group-Medford Neurology	Medford	Oregon
United States	Melbourne Internal Medicine Associates	Melbourne	Florida
United States	Allied Clinical Trials Inc.	Miami	Florida
United States	Miami Jewish Health Systems	Miami	Florida
United States	Miami Research Associates	Miami	Florida
United States	Pharmax Research Clinic, LLC	Miami	Florida
United States	Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Psychiatric Consultants, PC	Nashville	Tennessee
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Parker Jewish Institute for Health Care and Rehabilitation	New Hyde Park	New York
United States	Columbia University Medical Center	New York	New York
United States	New York University School of Medicine/Psychiarty	New York	New York
United States	Christiana Care Neurology Specialists	Newark	Delaware
United States	Pharmacology Research Institute	Newport Beach	California
United States	Neurocare, Inc.	Newton	Massachusetts
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	Research Center for Clinical Studies, Inc.	Norwalk	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	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	Nathan S. Kline Institute for Psychiatric Research	Orangeburg	New York
United States	Compass Research, LLC	Orlando	Florida
United States	Four Rivers Clinical Research, Inc.	Paducah	Kentucky
United States	Palm Beach Neurological Center, Advanced Research Consultants, Inc.	Palm Beach Gardens	Florida
United States	Neuro-Therapeutics, Inc.	Pasadena	California
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	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Neuroscience Research of the Berkshires	Pittsfield	Massachusetts
United States	Donald S. Marks, MD, PC	Plymouth	Massachusetts
United States	Neurostudies, Inc.	Port Charlotte	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Providence Health Service System, AD Center, Brain Institute	Portland	Oregon
United States	Summit Research Group, LLC	Portland	Oregon
United States	Global Medical Institutes, LLC	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	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 at Davis, Alzheimer's Disease Research Center	Sacramento	California
United States	Saint Louis University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Lous	Missouri
United States	Suncoast Neuroscience Associates, Inc.	Saint Petersburg	Florida
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	Neurological Research Institute	Santa Monica	California
United States	The Roskamp Institute, Inc	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	Avera Research Institute	Sioux Falls	South Dakota
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Springfield Neurology Associates, LLC	Springfield	Massachusetts
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, LLC	Tampa	Florida
United States	University of South Florida Suncoast Alzheimer's and Gerontology Center	Tampa	Florida
United States	Shore Neurology, PA	Toms River	New Jersey
United States	Northwest NeuroSpecialists, PLLC	Tucson	Arizona
United States	University of Arizona College of Medicine, Health Sciences 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 Psychiatric Consultants	Waukesha	Wisconsin
United States	Premiere Research Institute	West Palm Beach	Florida

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Austria,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No