Study of the Effect of SR57667B in Patients With Alzheimer's Disease

Study Overview
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Brief Summary
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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
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Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Official Title
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A Phase II, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: SR57667B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SR57667B|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer disease, nerve growth factors, Clinical Trial