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

This study has been completed.
Sponsor:
Information provided by:
Prana Biotechnology Limited
ClinicalTrials.gov Identifier:
NCT00471211
First received: May 8, 2007
Last updated: January 13, 2008
Last verified: January 2008
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: PBT2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Prana Biotechnology Limited:

Primary Outcome Measures:
  • Safety [ Time Frame: Study duration ]

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

Estimated Enrollment: 80
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471211

Locations
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, 3199
Melbourne, Victoria, Australia, 3081
Melbourne, Victoria, Australia, 3146
Melbourne, Victoria, Australia, 3101
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
Principal Investigator: Lars Lannfelt, Professor Uppsala University Hospital, Sweden
  More Information

No publications provided by Prana Biotechnology Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00471211     History of Changes
Other Study ID Numbers: PBT2-201
Study First Received: May 8, 2007
Last Updated: January 13, 2008
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014