CompletedPhase 3

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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Lead sponsor

Sanofi

Asset

xaliproden (SR57746A)

Listed sites

Recruiting sites

Enrollment

1,455

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDEFC2724

NCT IDNCT00104013

SecondarySR57746A

Timeline

Milestones

Study start2003-11 (month precision)

Study first posted2005-02-21estimated

Primary completion2007-11actual (month precision)

Study completion2007-11actual (month precision)

Last update posted2008-08-21estimated

Assets

Drug assets

xaliproden (SR57746A)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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 Status Examination score of 16 to 26 (inclusive)

-Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a 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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

2 endpoints

Primary/protocol endpoint

Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

Mini-Mental State Examination (MMSE)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.