Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01689233 |
Recruitment Status
:
Completed
First Posted
: September 21, 2012
Last Update Posted
: March 14, 2018
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Sponsor:
TauRx Therapeutics Ltd
Information provided by (Responsible Party):
TauRx Therapeutics Ltd
Tracking Information | |||
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First Submitted Date ICMJE | September 14, 2012 | ||
First Posted Date ICMJE | September 21, 2012 | ||
Last Update Posted Date | March 14, 2018 | ||
Study Start Date ICMJE | October 2012 | ||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01689233 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE |
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Descriptive Information | |||
Brief Title ICMJE | Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease | ||
Official Title ICMJE | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease | ||
Brief Summary | The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild Alzheimer's Disease. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer's Disease | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* 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 | ||
Actual Enrollment ICMJE |
800 | ||
Original Estimated Enrollment ICMJE |
500 | ||
Actual Study Completion Date | May 2016 | ||
Actual Primary Completion Date | May 2016 (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 | up to 89 Years (Child, Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Croatia, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States | ||
Removed Location Countries | Poland | ||
Administrative Information | |||
NCT Number ICMJE | NCT01689233 | ||
Other Study ID Numbers ICMJE | TRx-237-005 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | TauRx Therapeutics Ltd | ||
Study Sponsor ICMJE | TauRx Therapeutics Ltd | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | TauRx Therapeutics Ltd | ||
Verification Date | March 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |