Status:
COMPLETED
AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborating Sponsors:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).
Detailed Description
The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient...
Eligibility Criteria
Inclusion
- Diagnosis of probable AD
- 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
- Significant neurological disease other than AD
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00112073
Start Date
April 1 2005
End Date
December 1 2008
Last Update
March 14 2012
Active Locations (26)
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1
Cleo Roberts Center for Clinical Research / Sun Health Research Institute
Sun City, Arizona, United States, 85351
2
UC Irvine
Irvine, California, United States, 92697
3
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
4
Pharmacology Research Institute
Northridge, California, United States, 91324