Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
- Registration Number
- NCT00277810
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Diagnosis of probable Alzheimer's disease
- Current use of cholinesterase inhibitor
- Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study
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Exclusion Criteria
- Significant neurological disease other than AD
- Diagnosis of major depression
- History of stroke or other heart disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A lecozotan SR (SRA-333) - B lecozotan SR (SRA-333) - C lecozotan SR (SRA-333) -
- Primary Outcome Measures
Name Time Method All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales 6 mo extension study: week 24
- Secondary Outcome Measures
Name Time Method Score change from baseline to 24 weeks on functional and behavioral scales week 24