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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Alzheimer Disease

Treatments

Drug: SR57667B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00285025

EFC5286

SR57667B

Details and patient eligibility

About

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.

Full description

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.