---
title: "Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms"
nct_id: NCT02626572
overall_status: COMPLETED
phase: PHASE2
sponsor: Institut de Recherches Internationales Servier
study_type: INTERVENTIONAL
primary_condition: "Alzheimer's Disease"
countries: Brazil, Bulgaria, Chile, Czechia, Germany, Hungary, Japan, Mexico, Poland, Russia, Slovakia, South Africa
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02626572.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02626572"
ct_last_update_post_date: 2024-07-25
last_seen_at: "2026-05-12T07:12:51.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms

**Official Title:** 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.

**NCT ID:** [NCT02626572](https://clinicaltrials.gov/study/NCT02626572)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 500
- **Lead Sponsor:** Institut de Recherches Internationales Servier
- **Conditions:** Alzheimer's Disease
- **Start Date:** 2015-02
- **Completion Date:** 2017-09
- **CT.gov Last Update:** 2024-07-25

## Brief Summary

The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy of S47445 in co-administration with donepezil.

## Eligibility

- **Minimum age:** 55 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **S47445 5mg** (EXPERIMENTAL)
- **S47445 15mg** (EXPERIMENTAL)
- **S47445 50mg** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **S47445 5mg** (DRUG) — S47445 5 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
- **S47445 15mg** (DRUG) — S47445 15 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
- **S47445 50mg** (DRUG) — S47445 50 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
- **Placebo** (DRUG) — Placebo tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).

## Primary Outcomes

- **Change from baseline on 11-item ADAS-Cog** _(time frame: 24 weeks of treatment)_ — Cognition criterion

## Secondary Outcomes

- **Activities of Daily Living: Disability Assessment for Dementia (DAD)** _(time frame: baseline, week 12, week 24 and week 52)_
- **Cognition: 13-item ADAS-Cog** _(time frame: baseline, week 4, week 12, week 24, week 38 and week 52)_
- **Cognition: Mini-Mental State Examination (MMSE)** _(time frame: baseline, week 12, week 24 and week 52)_
- **Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)** _(time frame: baseline, week 4, week 12, week 24, week 38 and week 52)_
- **Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)** _(time frame: baseline, week 4, week 12, week 24 and week 52)_
- **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)_
- **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)_
- **Adverse events** _(time frame: through study completion, an average of 1 year)_
- **Vital signs: heart rate** _(time frame: baseline, week 4, week 12, week 24, week 38 and week 52)_
- **Vital signs: body temperature** _(time frame: baseline, week 4, week 12, week 24, week 38 and week 52)_
- **Vital signs: blood pressure** _(time frame: baseline, week 4, week 12, week 24, week 38 and week 52)_
- **Vital signs: body weight** _(time frame: baseline, week 12, week 24, week 38 and week 52)_
- **12-lead ECG** _(time frame: baseline, week 4, week 12, week 24, week 38 and week 52)_
- **Biological laboratory parameters: number of participants with abnomal laboratory values** _(time frame: baseline, week 4, week 12, week 24, week 38 and week 52)_
- **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)_

## Locations (78)

- Trial Tech Tecnologia em Pesquisa com Medicamentos, Curitiba, Brazil
- Hospital Universitario Walter Cantidio, Fortaleza, Brazil
- Clinilive - Centro de Pesquisas Clinicas, Maringá, Brazil
- Hospital das Clinicas de Porto Alegre, Porto Alegre, Brazil
- Hospital Oswaldo Cruz, Recife, Brazil
- Instituto Américo Bairral de Psiquiatria, Centro de Pesquisa, São Paulo, Brazil
- UNIFESP - Universidade Federal de Sao Paulo, São Paulo, Brazil
- UMHAT Sveti Georgi, Plovdiv, Bulgaria
- Medical University of Sofia, Aleksandrovska hospital, Sofia, Bulgaria
- National Hospital of Cardiology, Sofia, Bulgaria
- University Hospital Sveti Naum, Clinic of Neurology, Sofia, Bulgaria
- MHAT Sveta Marina, Varna, Bulgaria
- Clínica Oriente, Antofagasta, Chile
- Biomedica Research Group, Santiago, Chile
- Especialidades Medicas LYS, Santiago, Chile
- Hospital Santiago Oriente, Santiago, Chile
- Private practice, Santiago, Chile
- Saint Anne s.r.o. Psychiatricka ambulance, Brno, Czechia
- Brain-Soultherapy s.r.o., Kladno, Czechia
- Bialbi s.r.o., Litoměřice, Czechia
- AD71 s.r.o. Psychiatricka ambulance - Sudkova, Prague, Czechia
- CLINTRIAL s.r.o., Prague, Czechia
- FORBELI s.r.o., Neurologicka ambulance, Prague, Czechia
- Klinikum Altenburger Land GmbH Neurologische Klinik, Altenburg, Germany
- Neuropsychiatrisches Facharztzentrum Stiepel, Bochum, Germany
- Universitaetsklinikum des Saarlandes, Klinik für Psychiatrie und Psychotherapie, Homburg / Saar, Germany
- ISPG Institut für Studien zur Psychischen Gesundheit, Mannheim, Germany
- Pharmakologisches Studienzentrum Chemnitz GmbH, Mittweida, Germany
- Somni Bene, Institut fuer Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin, Germany
- Universitaetsklinik ULM, Poliklinik Neurologie, Ulm, Germany
- Private practice, Westerstede, Germany
- Semmelweis Egyetem Neurologiai Klinika, Budapest, Hungary
- Kenezy Gyula Korhaz es Rendelointezet, Debrecen, Hungary
- Vaszary Kolos Korhaz Esztergom Neurologiai Osztaly, Esztergom, Hungary
- Petz Aladar Megyei Oktato Korhaz Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly, Győr, Hungary
- Private practice, Kalocsa, Hungary
- B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly, Miskolc, Hungary
- Josa Andras Oktatokorhaz Pszihiatriai Osztaly, Nyíregyháza, Hungary
- Pecsi Tudomanyegyetem, Klinikai Kozpont Pszich. es Pszichoter. Klinika, Pécs, Hungary
- Szent-Gyorgyi Albert Klinikai Kozpont Pszichiatriai Klinika, Szeged, Hungary
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Pszichiatriai Osztaly, Székesfehérvár, Hungary
- Memory Clinic Ochanomizu, Bunkyō City, Japan
- Showakai Clinic, Kagoshima, Japan
- Rainbow & Sea Hospital, Karatsu-shi, Japan
- Kokan Clinic, Kawasaki-shi, Japan
- Social Medical Corporation Kojunkai Daido Hospital, Nagoya, Japan
- Nakano General Hospital, Nakano, Japan
- Private practice, Saitama-shi, Japan
- Private practice, Setagaya-ku, Japan
- Seishinkai Okehazama Hospital, Toyoake-shi, Japan
- Instituto Biomedico de Investigacion, Aguascalientes, Mexico
- Centro de Estudios Clinicos Y Especialidades Medicas Sc, Monterrey, Mexico
- Hospital Universitario de Nuevo León, Nuevo León, Mexico
- University Hospital of Saltillo, Saltillo, Mexico
- Nzoz Centrum Kultury, Higieny I Zdrowia Psychicznego, Bydgoszcz, Poland
- Krakowska Akademia Neurologii Centrum Neurologii Klinicznej, Krakow, Poland
- NZOZ Neuromed M. i M. Nastaj Sp. Partnerska, Lublin, Poland
- SENIOR Poradnia Psychogeriatryczna, Sopot, Poland
- Osrodek Alzheimerowski Sp. z o.o., Ścinawa, Poland
- Centrum Medyczne Neuroprotect, Warsaw, Poland
- Interregional Clinico-Diagnostical Centre, Kazan', Russia
- First Moscow State Medical University n.a.I.M. Sechenov Clinic of Neurology, Moscow, Russia
- Scientific Center of Mental Health Sect of AD and associated disord. Dpt of gerontopsychiatry, Moscow, Russia
- Scientific Center of Mental Health Sect of psychosis of elderly ages Dpt of gerontopsychiatry, Moscow, Russia
- City geriatric medico-social centre, Saint Petersburg, Russia
- Medical Military Academy n.a.S.M.Kirov, Saint Petersburg, Russia
- Psychoneuropathology Dispensary N 10, Saint Petersburg, Russia
- Co Ltd "LION-MED", Voronezh, Russia
- Private practice, Bratislava, Slovakia
- INVESTA, spol. s r. o. Psychiatricka ambulancia, Košice, Slovakia
- NsP Svatej Barbory Psychiatricke oddelenie, Rožňava, Slovakia
- Iatros International, Bloemfontein, South Africa
- Flexivest Fourteen Research Centre, Cape Town, South Africa
- Umhlanga Hospital, Durban, South Africa
- Excellentis Clinical Trial Consultants, George, South Africa
- Apollo Clinical Research, Johannesburg, South Africa
- Denmar Hospital, Pretoria, South Africa
- Somerset West Trial Centre, Somerset West, South Africa

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.trial tech tecnologia em pesquisa com medicamentos|curitiba||brazil` — added _(2026-05-12)_
- `locations.hospital universitario walter cantidio|fortaleza||brazil` — added _(2026-05-12)_
- `locations.clinilive - centro de pesquisas clinicas|maringá||brazil` — added _(2026-05-12)_
- `locations.hospital das clinicas de porto alegre|porto alegre||brazil` — added _(2026-05-12)_
- `locations.hospital oswaldo cruz|recife||brazil` — added _(2026-05-12)_
- `locations.instituto américo bairral de psiquiatria, centro de pesquisa|são paulo||brazil` — added _(2026-05-12)_
- `locations.unifesp - universidade federal de sao paulo|são paulo||brazil` — added _(2026-05-12)_
- `locations.umhat sveti georgi|plovdiv||bulgaria` — added _(2026-05-12)_
- `locations.medical university of sofia, aleksandrovska hospital|sofia||bulgaria` — added _(2026-05-12)_
- `locations.national hospital of cardiology|sofia||bulgaria` — added _(2026-05-12)_
- `locations.university hospital sveti naum, clinic of neurology|sofia||bulgaria` — added _(2026-05-12)_
- `locations.mhat sveta marina|varna||bulgaria` — added _(2026-05-12)_
- `locations.clínica oriente|antofagasta||chile` — added _(2026-05-12)_
- `locations.biomedica research group|santiago||chile` — added _(2026-05-12)_
- `locations.especialidades medicas lys|santiago||chile` — added _(2026-05-12)_
- `locations.hospital santiago oriente|santiago||chile` — added _(2026-05-12)_
- `locations.private practice|santiago||chile` — added _(2026-05-12)_
- `locations.saint anne s.r.o. psychiatricka ambulance|brno||czechia` — added _(2026-05-12)_
- `locations.brain-soultherapy s.r.o.|kladno||czechia` — added _(2026-05-12)_
- `locations.bialbi s.r.o.|litoměřice||czechia` — added _(2026-05-12)_
- `locations.ad71 s.r.o. psychiatricka ambulance - sudkova|prague||czechia` — added _(2026-05-12)_
- `locations.clintrial s.r.o.|prague||czechia` — added _(2026-05-12)_
- `locations.forbeli s.r.o., neurologicka ambulance|prague||czechia` — added _(2026-05-12)_
- `locations.klinikum altenburger land gmbh neurologische klinik|altenburg||germany` — added _(2026-05-12)_
- `locations.neuropsychiatrisches facharztzentrum stiepel|bochum||germany` — added _(2026-05-12)_
- `locations.universitaetsklinikum des saarlandes, klinik für psychiatrie und psychotherapie|homburg / saar||germany` — added _(2026-05-12)_
- `locations.university hospital of saltillo|saltillo||mexico` — added _(2026-05-12)_
- `locations.ispg institut für studien zur psychischen gesundheit|mannheim||germany` — added _(2026-05-12)_
- `locations.pharmakologisches studienzentrum chemnitz gmbh|mittweida||germany` — added _(2026-05-12)_
- `locations.somni bene, institut fuer medizinische forschung und schlafmedizin schwerin gmbh|schwerin||germany` — added _(2026-05-12)_
- `locations.universitaetsklinik ulm, poliklinik neurologie|ulm||germany` — added _(2026-05-12)_
- `locations.private practice|westerstede||germany` — added _(2026-05-12)_
- `locations.semmelweis egyetem neurologiai klinika|budapest||hungary` — added _(2026-05-12)_
- `locations.kenezy gyula korhaz es rendelointezet|debrecen||hungary` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02626572.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02626572*  
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