Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
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ClinicalTrials.gov Identifier: NCT01266525 |
Recruitment Status
:
Completed
First Posted
: December 24, 2010
Last Update Posted
: March 14, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | December 23, 2010 | |||
First Posted Date ICMJE | December 24, 2010 | |||
Last Update Posted Date | March 14, 2016 | |||
Study Start Date ICMJE | February 2011 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). [ Time Frame: Week 4, 12, and 24 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01266525 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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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 | Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil | |||
Official Title ICMJE | A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy | |||
Brief Summary | Primary Objective: - To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy Secondary Objectives:
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Detailed Description | The total study duration for each patient is approximatively 36 - 38 weeks broken down as follows:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
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 | Dementia Alzheimer's Type | |||
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 |
291 | |||
Original Estimated Enrollment ICMJE |
520 | |||
Actual Study Completion Date | January 2013 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Sex/Gender |
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Ages | 55 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, Canada, France, Germany, Italy, Poland, Portugal, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01266525 | |||
Other Study ID Numbers ICMJE | DRI10734 2010-022596-64 ( EudraCT Number ) U1111-1115-7535 ( Other Identifier: UTN ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sanofi | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |