Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
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.
1 other identifier
interventional
1,121
1 country
186
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
Typical duration for phase_3
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 10, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedNovember 25, 2013
October 1, 2013
4.3 years
December 10, 2007
October 30, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive and Functional
18 months
Secondary Outcomes (2)
Cognitive and Global
18 months
Imaging and biochemical biomarkers of disease status
18 months
Study Arms (3)
Bapineuzumab 0.5 mg/kg
EXPERIMENTALinfusion every 13 weeks for a total of 6 infusions
Placebo Dose
PLACEBO COMPARATORinfusion every 13 weeks for a total of 6 infusions.
Bapineuzumab 1.0 m/kg
EXPERIMENTALinfusion every 13 weeks for a total of 6 infusions.
Interventions
given by infusion every 13 weeks for a total of 6 infusions.
given by infusion every 13 weeks for a total of 6 infusions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (186)
University of Alabama Hospital (UAB)
Birmingham, Alabama, 35205, United States
Dedicated Clinical Research, Inc.
Goodyear, Arizona, 85395, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
HOPE Research Institute, LLC
Phoenix, Arizona, 85050, United States
Banner Research Institute
Sun City, Arizona, 85351, United States
University of Arizona College of Medicine, Health Sciences Center
Tucson, Arizona, 85724, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741, United States
Clinical Trials Inc.
Little Rock, Arkansas, 72205, United States
East Bay Physicians Medical Group
Berkeley, California, 94705, United States
AVI Clinical Research
Carson, California, 90746, United States
ATP Clinical Research, Inc
Costa Mesa, California, 92626, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Coordinated Clinical Research
La Jolla, California, 92037, United States
University of California San Diego
La Jolla, California, 92037, United States
Senior Clinical Trials, Inc
Laguna Hills, California, 92653, United States
Collaborative NeuroScience Network, Inc.
Long Beach, California, 90806, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Vintage Institute for Clinical Research, Inc
Los Angeles, California, 90035, United States
UCLA Department of Neurology
Los Angeles, California, 90095, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Neurology Center
Oceanside, California, 92056, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Neuro-Therapeutics Inc.
Pasadena, California, 91105, United States
Sutter Neuroscience Medical Group
Sacramento, California, 95816, United States
University of California Davis Alzheimer's Disease Research Center
Sacramento, California, 95817, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
University of California at San Francisco Medical Center at Parnassus
San Francisco, California, 94117, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Alpine Clinical Research Center
Boulder, Colorado, 80304, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
Associated Neurologists, PC
Danbury, Connecticut, 06810, United States
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, 06824, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Research Center for Clinical Studies, Inc
Norwalk, Connecticut, 06851, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057, United States
JEM Research, LLC
Atlantis, Florida, 33462, United States
Bradenton Research Center, Inc
Bradenton, Florida, 34205, United States
Quantum Laboratories, Inc.
Deerfield Beach, Florida, 33064, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, 33308, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Clinical Physiology Associates, Inc.
Fort Myers, Florida, 33916, United States
Emerald Coast Mood & Memory, PA.
Fort Walton Beach, Florida, 32547, United States
MD Clinical
Hallandale, Florida, 33009, United States
Mayo Clinic College of Medicine
Jacksonville, Florida, 32224, United States
Neurology Associates
Maitland, Florida, 32751, United States
Melbourne Internal Medicine Associates, MIMA
Melbourne, Florida, 32901, United States
Pharmax Research Clinic, LLC
Miami, Florida, 33126, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Allied Clinical Trials, Inc.
Miami, Florida, 33156, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Palm Beach Neurological Center/Advanced Research Consultants
Palm Beach Gardens, Florida, 33418, United States
Neurostudies, Inc
Port Charlotte, Florida, 33952, United States
The Roskamp Institute, Inc
Sarasota, Florida, 34243, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
Tampa, Florida, 33613, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, 33613, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Emory University, School of Medicine
Atlanta, Georgia, 30322, United States
Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, 30327, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342, United States
Medical Research and Health Educational Foundation, Inc
Columbus, Georgia, 31909, United States
DeKalb Neurology Associates, LLC
Decatur, Georgia, 30033, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, 60007, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, 62794, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Mid America Neuroscience Institute
Lenexa, Kansas, 66214, United States
Associates in Neurology, PSC
Lexington, Kentucky, 40513, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 70112, United States
J. Gary Booker, MD, APMC
Shreveport, Louisiana, 71104, United States
Maine Medical Partners Neurology
Scarborough, Maine, 04074, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
ActivMed Practices and Research, Inc
Haverhill, Massachusetts, 01830, United States
Neurocare, Inc
Newton, Massachusetts, 02459, United States
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, 01201, United States
Donald S. Marks, MD, P.C.
Plymouth, Massachusetts, 02360, United States
Springfield Neurology Associates
Springfield, Massachusetts, 01104, United States
University of Michigan
Ann Arbor, Michigan, 48105, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Borgess Medical Center/Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Saint Luke's Hospital, Mid America Brain and Stroke Institute
Kansas City, Missouri, 64111, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
St. Louis University School of Medicine
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Deaconess Billings Clinical Research Center
Billings, Montana, 59101, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2045, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
The NeuroCognitive Institute
Mount Arlington, New Jersey, 07856, United States
Alzheimer's Research Corporation (ARC)
Paterson, New Jersey, 08759, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, 08084, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
Neurological Associates Albany PC
Albany, New York, 12208, United States
Neuroscience Research Center at Albany Medical Center
Albany, New York, 12208, United States
Five Towns Neuroscience Research
Cedarhurst, New York, 11516, United States
Advanced BioBehavioral Sciences
Elmsford, New York, 10523, United States
Empire Neurology, PC
Latham, New York, 12110, United States
Neurological Care of CNY
Liverpool, New York, 13088, United States
Parker Jewish Institute for Health Care & Rehabilitation
New Hyde Park, New York, 11040, United States
NYU School of Medicine/Psychiatry
New York, New York, 10016, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, 10962, United States
University of Rochester Medical Center @ Monroe Community Hospital
Rochester, New York, 14620, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Clinical Trials of America, Inc
Hickory, North Carolina, 28601, United States
New Hope Clinical Research
Hickory, North Carolina, 28601, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
Beachwood, Ohio, 44122, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718, United States
NeuroCare Center, Inc
Canton, Ohio, 44718, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Neurology Specialists, Inc.
Dayton, Ohio, 45417, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, 73112, United States
Providence Medical Group-Medford Neurology
Medford, Oregon, 97504, United States
Summit Research Group, LLC
Portland, Oregon, 97210, United States
Providence Health Service System, AD Center, Brain Institute
Portland, Oregon, 97225, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
Abington Neurological Assoc
Abington, Pennsylvania, 19001, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Penn Memory Center
Philadelphia, Pennsylvania, 19104, United States
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, 19107, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206, United States
University of Virginia
Pittsburgh, Pennsylvania, 15213, United States
Universtiy of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Neurology Clinic, PC
Cordova, Tennessee, 38018, United States
Psychiatric Consultants, PC
Franklin, Tennessee, 37067, United States
East Tennessee State University
Johnson City, Tennessee, 37614-1707, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Texas Neurology, PA
Dallas, Texas, 75214, United States
University of North Texas/Health Sciences Center-Fort Worth
Fort Worth, Texas, 76106, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Integra Clinical Research, LLC
San Antonio, Texas, 78231, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
University of Utah, Dept. of Neurology
Salt Lake City, Utah, 84108, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Innovative Clinical Research Center
Alexandria, Virginia, 22304, United States
Alliance Research Group, LLC
Richmond, Virginia, 23230, United States
University of Washington Veterans Affairs
Seattle, Washington, 98108, United States
Pacific Medical Centers
Seattle, Washington, 98144, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (6)
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.
PMID: 30412493DERIVEDSamtani 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.
PMID: 29854935DERIVEDXu 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.
PMID: 29854934DERIVEDKetter 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.
PMID: 28269765DERIVEDLiu 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.
PMID: 26208959DERIVEDSalloway 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.
PMID: 24450891DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
December 10, 2007
First Posted
December 17, 2007
Study Start
December 1, 2007
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
November 25, 2013
Record last verified: 2013-10