NCT00471211
Completed
Phase 2
A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Three-Group Study to Assess the Safety, Tolerability and Efficacy of Two Dose Levels of PBT2 to Slow Progression of Disease in Patients With Early Alzheimer's Disease
Prana Biotechnology Limited0 sites80 target enrollmentDecember 2006
ConditionsAlzheimer's Disease
DrugsPBT2
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Prana Biotechnology Limited
- Enrollment
- 80
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease treated with an acetylcholinesterase inhibitor.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosis of probable early Alzheimer's disease
- •stable dose of acetylcholinesterase inhibitor
- •community dwelling
- •stable medical condition
Exclusion Criteria
- •unstable and significant medical conditions
- •recurrent major psychiatric disorder
- •treatment with memantine
Outcomes
Primary Outcomes
Safety
Time Frame: Study duration
Secondary Outcomes
- Change from baseline in biomarkers; Change from baseline in cognitive and global function scales(Study duration)
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