Clinical trial NCT00575055: Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
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 Carriers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2007-12-17
Enrollment: 1121
Sex: ALL
Minimum age (years): 50
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 200 study sites in the US and Canada 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cognitive and Functional
timeFrame: 18 months
Secondary outcomes:
measure: Cognitive and Global
timeFrame: 18 months
measure: Imaging and biochemical biomarkers of disease status
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital (UAB)
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: Vintage Institute for Clinical Research, Inc
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 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 at San Francisco Medical Center at Parnassus
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 CT, 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 Health Services
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, P.A.
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 & Memory, PA.
state: Florida
city: Ft. Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
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, MIMA
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: 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
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies, Inc
state: Florida
city: Sarasota
country: United States
facility: The Roskamp Institute, Inc
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: St Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
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 Educational 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 Neurosciences Institute
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: University of Kansas Medical Center
state: Kansas
city: Lenexa
country: United States
facility: Mid America 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: Louisiana State University Health Sciences Center
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: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
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, P.C.
state: Massachusetts
city: Springfield
country: United States
facility: Springfield Neurology Associates
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
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: Grand Rapids
country: United States
facility: Saint Mary's Health Care
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: Saint Luke's Hospital, Mid America Brain and Stroke Institute
state: Missouri
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University School of Medicine
state: Missouri
city: St. Louis
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: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
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 (ARC)
state: New Jersey
city: Mount Arlington
country: United States
facility: The NeuroCognitive Institute
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Stratford
country: United States
facility: University of Medicine and Dentistry of New Jersey
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 Albany PC
state: New York
city: Albany
country: United States
facility: Neuroscience Research Center at Albany Medical Center
state: New York
city: Cedarhurst
country: United States
facility: Five Towns Neuroscience Research
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 CNY
state: New York
city: New Hyde Park
country: United States
facility: Parker Jewish Institute for Health Care & Rehabilitation
state: New York
city: New York
country: United States
facility: NYU School of Medicine/Psychiatry
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
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: Hickory
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Beachwood
country: United States
facility: University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Canton
country: United States
facility: NeuroCare Center, Inc
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
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 & Sciences University
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Assoc
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 Virginia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Universtiy 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: N. 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, PC
state: Tennessee
city: Franklin
country: United States
facility: Psychiatric Consultants, PC
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: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas/Health Sciences Center-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: 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: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Brashear HR, Ketter N, Bogert J, Di J, Salloway SP, Sperling R. Clinical Evaluation of Amyloid-Related Imaging Abnormalities in Bapineuzumab Phase III Studies. J Alzheimers Dis. 2018;66(4):1409-1424. doi: 10.3233/JAD-180675.
citation: Ketter N, Brashear HR, Bogert J, Di J, Miaux Y, Gass A, Purcell DD, Barkhof F, Arrighi HM. Central Review of Amyloid-Related Imaging Abnormalities in Two Phase III Clinical Trials of Bapineuzumab in Mild-To-Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;57(2):557-573. doi: 10.3233/JAD-160216.
citation: Samtani MN, Xu SX, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease assessment scale-cognitive 11-item progression model in mild-to-moderate Alzheimer's disease trials of bapineuzumab. Alzheimers Dement (N Y). 2015 Oct 9;1(3):157-169. doi: 10.1016/j.trci.2015.09.001. eCollection 2015 Nov.
citation: Liu E, Schmidt ME, Margolin R, Sperling R, Koeppe R, Mason NS, Klunk WE, Mathis CA, Salloway S, Fox NC, Hill DL, Les AS, Collins P, Gregg KM, Di J, Lu Y, Tudor IC, Wyman BT, Booth K, Broome S, Yuen E, Grundman M, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Amyloid-beta 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. Neurology. 2015 Aug 25;85(8):692-700. doi: 10.1212/WNL.0000000000001877. Epub 2015 Jul 24.
citation: Xu SX, Samtani MN, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease progression model using disability assessment for dementia scores from bapineuzumab trials. Alzheimers Dement (N Y). 2015 Jul 21;1(2):141-149. doi: 10.1016/j.trci.2015.06.005. eCollection 2015 Sep.
citation: Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, Sabbagh M, Honig LS, Porsteinsson AP, Ferris S, Reichert M, Ketter N, Nejadnik B, Guenzler V, Miloslavsky M, Wang D, Lu Y, Lull J, Tudor IC, Liu E, Grundman M, Yuen E, Black R, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):322-33. doi: 10.1056/NEJMoa1304839.