Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease
Phase 2
Completed
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT00471211
- Lead Sponsor
- Prana Biotechnology Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety Study duration
- Secondary Outcome Measures
Name Time Method Change from baseline in biomarkers; Change from baseline in cognitive and global function scales Study duration