Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease
This study has been completed.
Sponsor:
Prana Biotechnology Limited
Information provided by:
Prana Biotechnology Limited
ClinicalTrials.gov Identifier:
NCT00471211
First received: May 8, 2007
Last updated: January 13, 2008
Last verified: January 2008
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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
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 May 16, 2013