Study of the Effect of SR57667B in Patients With Alzheimer's Disease
Phase 2
Completed
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00285025
- Lead Sponsor
- Sanofi
- 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 patients with mild to moderate AD.
Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.
- Detailed Description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
- Secondary Outcome Measures
Name Time Method MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.