NCT00021723TerminatedPhase 2
Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
JANSSEN Alzheimer Immunotherapy Research & Development, LLC20 sites in 1 country375 target enrollmentStarted: September 1, 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 375
- Locations
- 20
Study Overview
Brief Summary
A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.
Detailed Description
The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.
Exclusion Criteria
- Not provided
Investigators
Study Sites (20)
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