CompletedPhase 2

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

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

Lead sponsor

Sanofi

Asset

SR57667B

Listed sites

Recruiting sites

Enrollment

500

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26•Study partner/caregiver required•AD symptomatic therapy: stable

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDEFC5286

NCT IDNCT00285025

SecondarySR57667B

Timeline

Milestones

Study start2005-03 (month precision)

Study completion2005-09 (month precision)

Study first posted2006-02-01estimated

Last update posted2006-02-01estimated

Assets

Drug assets

SR57667B

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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.

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

ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.

ADAS-Cog

descriptive

Secondary/protocol endpoint

MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.

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.