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CompletedPhase 2

Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease

Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease

Lead sponsor

Sanofi

Asset

SR57667B

Listed sites

Recruiting sites

Enrollment

390

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Adverse events recorded quarterly

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 IDLTS5283

NCT IDNCT00285077

Timeline

Milestones

Study start2004-03 (month precision)

Study first posted2006-02-01estimated

Primary completion2006-11actual (month precision)

Study completion2006-11actual (month precision)

Last update posted2008-12-23estimated

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

•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.

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.

Coverage by outcome category

Global cognition

Safety / tolerability / PK

Global cognition

1 endpoint

Secondary/protocol endpoint

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

ADAS-Cog

descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Adverse events recorded quarterly.

event count, event

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.