CompletedPhase 2

Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms

Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms. A 24-week International, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase II Study in Monotherapy Followed by an Optional 28-week Extension Period in Co-administration With Donepezil.

Lead sponsor

Institut de Recherches Internationales Servier

Asset

S47445

Listed sites

Recruiting sites

Enrollment

500

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE 15-24

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 number2014-001519-38

Org study IDCL2-47445-011

NCT IDNCT02626572

Timeline

Milestones

Study start2015-02 (month precision)

Study first posted2015-12-10estimated

Primary completion2017-09actual (month precision)

Study completion2017-09actual (month precision)

Last update posted2024-07-25actual

Assets

Drug assets

S47445

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Out-patients

•Able to perform neuropsychological tests

•Have a responsible informant

•DSM-IV-TR criteria for Dementia of the Alzheimer's Disease Type

•Mini mental State Examination (MMSE) = 15-24 both inclusive

•National Institute of Mental Health (NIMH) provisional criteria for depression in AD (NIMH-dAD)

•Cornell Scale for Depression in Dementia total score > or = 8

•Patients who have never been treated with AD treatments or patients who have stopped AD treatment whatever the reason

•Patients either not currently treated with an antidepressant or patients being treated with an antidepressant at the recommended dose for at least 8 weeks without clinical efficacy, who can stop this treatment according to the investigator's opinion

Exclusion criteria

•Patients not able to read or write

•Patients having participated in a study testing disease modifying therapy for AD, or in another study with administration of investigational drug or device within the previous 3 months prior to selection visit

•Depressive symptoms that, in investigator's judgment, are clearly due to a medical condition other than AD, or are a direct result of non-mood related dementia symptoms

•History of epilepsy or solitary seizure

•Medical history of Major Depressive Disorder more than 3 years before onset of the disease, treated with antidepressive drugs or electroconvulsive therapy

•Severe or unstable disease of any type that could interfere with safety and efficacy assessments

•Alcohol abuse or drug abuse or addiction, as judged by the clinician (excluding nicotine)

•Clinically relevant lactose intolerance

•Antidepressant treatment not stopped for at least 3 weeks before inclusion

•Significant worsening of depressive symptoms or high suicidal risk according to investigator's judgment

•For optional extension phase: medically instable Chronic Obstructive Pulmonary Disease and asthma, known hypersensitivity to donepezil hydrochloride or piperidine derivatives

Endpoints (16)

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

Safety / tolerability / PK

Global cognition

Behavior / neuropsychiatric

Function / daily living

Other clinical outcomes

Other (unclassified)

Global cognition

3 endpoints

Primary/protocol endpoint

Change from baseline on 11-item ADAS-Cog

Time frame:24 weeks of treatment

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Cognition: 13-item ADAS-Cog

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

ADAS-Cog

descriptive

Secondary/protocol endpoint

Cognition: Mini-Mental State Examination (MMSE)

Time frame:baseline, week 12, week 24 and week 52

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Activities of Daily Living: Disability Assessment for Dementia (DAD)

Time frame:baseline, week 12, week 24 and week 52

descriptive

Behavior / neuropsychiatric

3 endpoints

Secondary/protocol endpoint

Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

descriptive

Secondary/protocol endpoint

Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)

Time frame:baseline, week 4, week 12, week 24 and week 52

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16)

Time frame:baseline, week 4, week 12, week 24, week 28, week 38 and week 52

descriptive

Safety / tolerability / PK

7 endpoints

Secondary/protocol endpoint

Adverse events

Time frame:through study completion, an average of 1 year

event count, event

Secondary/protocol endpoint

Vital signs: heart rate

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

descriptive

Secondary/protocol endpoint

Vital signs: body temperature

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

descriptive

Secondary/protocol endpoint

Vital signs: blood pressure

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

descriptive

Secondary/protocol endpoint

Vital signs: body weight

Time frame:baseline, week 12, week 24, week 38 and week 52

descriptive

Secondary/protocol endpoint

12-lead ECG

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

descriptive

Secondary/protocol endpoint

Biological laboratory parameters: number of participants with abnomal laboratory values

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC)

Time frame:baseline, week 24 and week 52

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds)

Time frame:baseline, week 4, week 12, week 24, week 38 and week 52

descriptive

Publications (1)

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

Bernard K, Gouttefangeas S, Bretin S, Galtier S, Robert P, Holthoff-Detto V, Cummings J, Pueyo M. A 24-week double-blind placebo-controlled study of the efficacy and safety of the AMPA modulator S47445 in patients with mild to moderate Alzheimer's disease and depressive symptoms. Alzheimers Dement (N Y). 2019 Jun 24;5:231-240. doi: 10.1016/j.trci.2019.04.002. eCollection 2019.
PMID31297437via RESULT

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.