CompletedPhase 2

Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy

Lead sponsor

Sanofi

Assets

Donepezil / SAR110894

Listed sites

Recruiting sites

Enrollment

291

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•ADAS-Cog

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

Eudract number2010-022596-64

Org study IDDRI10734

NCT IDNCT01266525

Secondary IDU1111-1115-7535UTN

Timeline

Milestones

Study first posted2010-12-24estimated

Study start2011-02 (month precision)

Primary completion2013-01actual (month precision)

Study completion2013-01actual (month precision)

Last update posted2016-03-14estimated

Assets

Drug assets

Donepezil SAR110894

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes).

•Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit

Exclusion criteria

•Age <55 years old.

•Psychotic features, agitation, or behavioral problems within the last 3 months.

•Patients unable to comply with ophthalmologic monitoring.

•Lack of consistent and reliable caregiver.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Endpoints (5)

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

Function / daily living

Other (unclassified)

Global cognition

3 endpoints

Primary/protocol endpoint

Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).

Time frame:Week 4, 12, and 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")

Time frame:Week 4, 12, and 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in the Mini Mental State Examination (MMSE) total score

Time frame:Week 4, 12, and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score

Time frame:Week 4, 12, and 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment

Time frame:Week 4, 12, and 24

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.