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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 18, 2008 | ||||
| Last Updated Date | September 16, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00663936 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease | ||||
| Official Title ICMJE | A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate Alzheimer's Disease | ||||
| Brief Summary | The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Alzheimer's Disease | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 326 | ||||
| Estimated Completion Date | September 2011 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00663936 | ||||
| Responsible Party | Dr. Katsumi Shimizu, Development Management Department, Toyama Chemical Co., Ltd. | ||||
| Study ID Numbers ICMJE | AA4437420 | ||||
| Study Sponsor ICMJE | Toyama Chemical Co., Ltd. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | Toyama Chemical Co., Ltd. | ||||
| Verification Date | September 2009 | ||||
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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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