18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Sanofi

Status and phase

Completed

Phase 3

Conditions

Alzheimer Disease

Treatments

Drug: xaliproden (SR57746A)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00103649

EFC2946

SR57746

Details and patient eligibility

About

The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

Enrollment

1,306 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria
- Mild to moderate degree of severity of dementia as assessed by the Mini-Mental State Examination score of 16 to 26 (inclusive)
- Potential participant may be treated with conventional Alzheimer's disease therapy and must be on stable dose for at least 6 months prior to the randomization and during the entire study period
- Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
- Mother tongue is English, Spanish or French (oral and written fluency)
- Signed informed consent from potential participant or legal representative and identified caregiver

Exclusion criteria

Potential participant with any other cause of dementia.
Potential participant with serious health problems other than Alzheimer's disease
Use of an investigational drug within two months prior to randomization or during this study