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
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Sponsor:
Prana Biotechnology Limited
Information provided by:
Prana Biotechnology Limited
Tracking Information | ||||
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First Submitted Date ICMJE | May 8, 2007 | |||
First Posted Date ICMJE | May 9, 2007 | |||
Last Update Posted Date | January 16, 2008 | |||
Study Start Date ICMJE | December 2006 | |||
Actual 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 Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer's Disease | |||
Intervention ICMJE | Drug: PBT2 | |||
Study Arms | 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. | |||
* 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 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | December 2007 | |||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Prana Biotechnology Limited | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Prana Biotechnology Limited | |||
Verification Date | January 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |