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

January 13, 2008 updated by: Prana Biotechnology Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
      • Sydney, New South Wales, Australia, 2077
    • South Australia
      • Adelaide, South Australia, Australia, 5011
    • Victoria
      • Melbourne, Victoria, Australia, 3081
      • Melbourne, Victoria, Australia, 3101
      • Melbourne, Victoria, Australia, 3146
      • Melbourne, Victoria, Australia, 3199
  • Sweden
      • Falkoping, Sweden, 521 85
      • Kalix, Sweden, 952 81
      • Kalmar, Sweden, 391 85
      • Lund, Sweden, 85
      • Malmo, Sweden, 205 20
      • Stockholm, Sweden, 112 98
      • Umea, Sweden, 901 85
      • Uppsala, Sweden, 751 85

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: Study duration
Study duration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prana Biotechnology Limited

Investigators

  • Principal Investigator: Lars Lannfelt, Professor, Uppsala University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 8, 2007

First Submitted That Met QC Criteria

May 8, 2007

First Posted (Estimate)

May 9, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2008

Last Update Submitted That Met QC Criteria

January 13, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBT2-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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