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
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | May 8, 2007 | |||
| Last Updated Date | January 13, 2008 | |||
| Start Date ICMJE | December 2006 | |||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: Study duration ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00471211 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Change from baseline in biomarkers; Change from baseline in cognitive and global function scales [ Time Frame: Study duration ] | |||
| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Alzheimer's Disease | |||
| Intervention ICMJE | Drug: PBT2 | |||
| Study Arm (s) | Not Provided | |||
| Publications * | Lannfelt L, Blennow K, Zetterberg H, Batsman S, Ames D, Harrison J, Masters CL, Targum S, Bush AI, Murdoch R, Wilson J, Ritchie CW; PBT2-201-EURO study group. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008 Sep;7(9):779-86. doi: 10.1016/S1474-4422(08)70167-4. Epub 2008 Jul 30. Erratum in: Lancet Neurol. 2009 Nov;8(11):981. | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 80 | |||
| Completion Date | December 2007 | |||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | |||
| Ages | 56 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Australia, Sweden | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00471211 | |||
| Other Study ID Numbers ICMJE | PBT2-201 | |||
| Has Data Monitoring Committee | Yes | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Prana Biotechnology Limited | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| Information Provided By | Prana Biotechnology Limited | |||
| Verification Date | January 2008 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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