AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00112073
Last Updated: 2012-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
234 participants
INTERVENTIONAL
2005-04-30
2008-12-31
Brief Summary
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Detailed Description
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This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.15 mg/kg active bapineuzumab
bapineuzumab
IV, Q13w
0.15 mg/kg placebo
placebo
IV Q13w
0.5 mg/kg active bapineuzumab
bapineuzumab
IV, Q13w
0.5 mg/kg placebo
placebo
IV Q13w
1.0 mg/kg active bapineuzumab
bapineuzumab
IV, Q13w
1.0 mg/kg placebo
placebo
IV Q13w
2.0 mg/kg active bapineuzumab
bapineuzumab
IV, Q13w
2.0 mg/kg placebo
placebo
IV Q13w
Interventions
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bapineuzumab
IV, Q13w
placebo
IV Q13w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age from 50 to 85 years
* Rosen Modified Hachinski Ischemic score less than or equal to 4
* Magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
* Fluency in English
* Stable doses of medications
Exclusion Criteria
* Major psychiatric disorder
* Significant systemic illness
* History of stroke or seizure
* Weight greater than 120 kg (264 lbs.)
* History of autoimmune disease
* Smoking more than 20 cigarettes per day
* Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
* Prior treatment with experimental immunotherapeutics or vaccines for AD
* Presence of pacemakers or foreign metal objects in the eyes, skin, or body
50 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Responsible Party
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Locations
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Cleo Roberts Center for Clinical Research / Sun Health Research Institute
Sun City, Arizona, United States
UC Irvine
Irvine, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Northridge, California, United States
UCSD Shiley-Marcos Alzheimer's Disease Research Center
San Diego, California, United States
Memory & Aging Center, UCSF
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Mayo Clinic - Department of Neurology
Jacksonville, Florida, United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, United States
Behavioral Neurology
Boston, Massachusetts, United States
University of Michigan Health System, Department of Neurology
Ann Arbor, Michigan, United States
Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center
Rochester, Minnesota, United States
The Memory Enhancement Center
Long Branch, New Jersey, United States
Sergievsky Center, Columbia University
New York, New York, United States
University of Rochester / Monroe Community Hospital
Rochester, New York, United States
Department of Psychiatry and Behavioral Sciences
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Arrighi HM, Barakos J, Barkhof F, Tampieri D, Jack C Jr, Melancon D, Morris K, Ketter N, Liu E, Brashear HR. Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer's disease treated with bapineuzumab: a historical, prospective secondary analysis. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):106-12. doi: 10.1136/jnnp-2014-309493. Epub 2015 Feb 10.
Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, Grundman M, Liu E; AAB-001 201/202 Investigators. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Arch Neurol. 2012 Aug;69(8):1002-10. doi: 10.1001/archneurol.2012.90.
Other Identifiers
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AAB-001-201
Identifier Type: -
Identifier Source: org_study_id
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