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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-05-08
• Study First Submitted QC: 2007-05-08
• Study First Posted: 2007-05-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-13
• Last Update Posted: 2008-01-16

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