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

Tracking Information

First Received Date ^ICMJE

May 8, 2007

Last Updated Date

January 13, 2008

Start Date ^ICMJE

December 2006

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: Study duration ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00471211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in biomarkers; Change from baseline in cognitive and global function scales [ Time Frame: Study duration ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: PBT2

Study Arms / Comparison Groups

Publications *

Lannfelt L, Blennow K, Zetterberg H, Batsman S, Ames D, Harrison J, Masters CL, Targum S, Bush AI, Murdoch R, Wilson J, Ritchie CW; PBT2-201-EURO study group. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008 Sep;7(9):779-86. Epub 2008 Jul 30.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

56 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00471211

Responsible Party

Study ID Numbers ^ICMJE

PBT2-201

Study Sponsor ^ICMJE

Prana Biotechnology Limited

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lars Lannfelt, Professor

Uppsala University Hospital, Sweden

Information Provided By

Prana Biotechnology Limited

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP