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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00277810 |
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Date of registration:
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12/01/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
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Scientific title:
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A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study of 3 Doses of Lecozotan (SRA-333) SR in Outpatients With Mild to Moderate Alzheimer's Disease Treated With a Cholinesterase Inhibitor |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00277810 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Argentina
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Australia
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Canada
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Finland
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France
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Italy
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Poland
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South Africa
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Spain
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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
Exclusion Criteria:
- Significant neurological disease other than AD
- Diagnosis of major depression
- History of stroke or other heart disease
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Drug: lecozotan SR (SRA-333)
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Primary Outcome(s)
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All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
[Time Frame: 6 mo extension study: week 24]
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Secondary Outcome(s)
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Score change from baseline to 24 weeks on functional and behavioral scales
[Time Frame: week 24]
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Secondary ID(s)
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3098B1-203, 3098B1-204
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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