Status:
COMPLETED
Study of the Effect of SR57667B in Patients With Alzheimer's Disease
Lead Sponsor:
Sanofi
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in p...
Detailed Description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Eligibility Criteria
Inclusion
- Male / female outpatients.
- Age \> 50 years at screening.
- Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score \> 12 and \< 26.
- Untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
- Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
- Presence of a reliable caregiver.
- Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures
Exclusion
- Any cause of dementia not due to Alzheimer's disease, Delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
- Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
- Females who are pregnant or breast-feeding. Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit, and must use an acceptable method of birth control.
- Severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
- Use of CYP3A4 strong inhibitors
- Evidence (detected by history, physical examination and / or laboratory / ECG tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00285025
Start Date
March 1 2005
End Date
September 1 2005
Last Update
February 1 2006
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