Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease
NCT ID: NCT01254773
Last Updated: 2014-05-09
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
146 participants
INTERVENTIONAL
2010-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bapineuzumab SC Dose 1; 2 mg
Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Bapineuzumab SC Dose 2; 7 mg
Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Bapineuzumab SC Dose 3; 20 mg
Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Placebo
No interventions assigned to this group
Interventions
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Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Eligibility Criteria
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Inclusion Criteria
* Age from 50 to less than 89
* Mini-Mental Status Exam score of 18-26 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
* Amyloid burden on screening PET scan consistent with diagnosis of AD
Exclusion Criteria
* 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
50 Years
89 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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Janssen AI Investigational Site
Tucson, Arizona, United States
Janssen AI Investigational Site
Tucson, Arizona, United States
Janssen AI Investigational Site
La Habra, California, United States
Janssen AI Investigational Site
Lomita, California, United States
Janssen AI Investigational Site
Long Beach, California, United States
Janssen AI Investigational Site
Oceanside, California, United States
Janssen AI Investigational Site
Pasadena, California, United States
Janssen AI Investigational Site
Santa Monica, California, United States
Janssen AI Investigational Site
Sherman Oaks, California, United States
Janssen AI Investigational Site
Deerfield Beach, Florida, United States
Janssen AI Investigational Site
Delray Beach, Florida, United States
Janssen AI Investigational Site
Fort Meyers, Florida, United States
Janssen AI Investigational Site
Miami Springs, Florida, United States
Janssen AI Investigational Site
South Miami, Florida, United States
Janssen AI Investigational Site
Atlanta, Georgia, United States
Janssen AI Investigational Site
Indianapolis, Indiana, United States
Janssen AI Investigational Site
Kansas City, Kansas, United States
Janssen AI Investigational Site
Lexington, Kentucky, United States
Janssen AI Investigational Site
Plymouth, Massachusetts, United States
Janssen AI Investigational Site
Farmington Hills, Michigan, United States
Janssen AI Investigational Site
Creve Coeur, Missouri, United States
Janssen AI Investigational Site
St Louis, Missouri, United States
Janssen AI Investigational Site
Latham, New York, United States
Janssen AI Investigational Site
Winston-Salem, North Carolina, United States
Janssen AI Investigational Site
Dayton, Ohio, United States
Janssen AI Investigational Site
Portland, Oregon, United States
Janssen AI Investigational Site
Philadelphia, Pennsylvania, United States
Janssen AI Investigational Site
Providence, Rhode Island, United States
Countries
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Other Identifiers
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AAB-001-SC-ALZ-2003
Identifier Type: -
Identifier Source: org_study_id
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