Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471211
• Other study ID #: PBT2-201
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2007
• Last updated: January 13, 2008
• Start date: December 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Prana Biotechnology Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• PBT2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prana Biotechnology Limited

Countries where clinical trial is conducted

Australia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		Study duration
Secondary	Change from baseline in biomarkers; Change from baseline in cognitive and global function scales		Study duration