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

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ClinicalTrials.gov Identifier: NCT00471211
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : January 16, 2008
Sponsor:
Information provided by:
Prana Biotechnology Limited

Study Description
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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
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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

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Arms and Interventions
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Outcome Measures
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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
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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
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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
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
Principal Investigator: Lars Lannfelt, Professor Uppsala University Hospital, Sweden
More Information
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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
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders