Long-Term Safety Extension With 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

NCT00285077

LTS5283

Details and patient eligibility

About

The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).

A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.

Full description

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

Enrollment

390 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who have participated in Study EFC5286 and completed the study.
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 specifically for this LTS5283 extension.

Exclusion criteria

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.