We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00471211
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : January 16, 2008
Sponsor:
Information provided by:
Pranabio

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: PBT2 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : December 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety [ Time Frame: Study duration ]

Secondary Outcome Measures :
  1. Change from baseline in biomarkers; Change from baseline in cognitive and global function scales [ Time Frame: Study duration ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471211


Locations
Layout table for location information
Australia, New South Wales
Sydney, New South Wales, Australia, 2031
Sydney, New South Wales, Australia, 2077
Australia, South Australia
Adelaide, South Australia, Australia, 5011
Australia, 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
Sponsors and Collaborators
Prana Biotechnology Limited
Investigators
Layout table for investigator information
Principal Investigator: Lars Lannfelt, Professor Uppsala University Hospital, Sweden
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00471211    
Other Study ID Numbers: PBT2-201
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders