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Sponsored by: |
Prana Biotechnology Limited |
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Information provided by: | Prana Biotechnology Limited |
ClinicalTrials.gov Identifier: | NCT00471211 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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) |
Ages Eligible for Study: | 56 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Kalix, Sweden, 952 81 | |
Umea, Sweden, 901 85 | |
Stockholm, Sweden, 112 98 | |
Malmo, Sweden, 205 20 | |
Falkoping, Sweden, 521 85 | |
Uppsala, Sweden, 751 85 | |
Kalmar, Sweden, 391 85 | |
Lund, Sweden, 85 |
Principal Investigator: | Lars Lannfelt, Professor | Uppsala University Hospital, Sweden |
Study ID Numbers: | PBT2-201 |
Study First Received: | May 8, 2007 |
Last Updated: | January 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00471211 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Disease Progression Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |