Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
Phase 2
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT00174525
- Lead Sponsor
- Pharmacology Research Institute
- Brief Summary
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosis of probable AD
- Age from 50 to 85 years, inclusive
- 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
- Significant neurological disease other than AD
- Major psychiatric disorder
- Significant systemic illness
- History of stroke or seizure
- Weight greater than 120kg (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety assessments
- Secondary Outcome Measures
Name Time Method Blood levels of administered study drug Cognitive and functional assessments
Trial Locations
- Locations (1)
Pharmacology Research Institute
🇺🇸Northridge, California, United States
Pharmacology Research Institute🇺🇸Northridge, California, United States