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

PHASE2CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

September 30, 2017

Study Completion Date

September 30, 2017

Conditions
Alzheimer's Disease
Interventions
DRUG

S47445 5mg

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).

DRUG

S47445 15mg

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).

DRUG

S47445 50mg

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).

DRUG

Placebo

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).

Trial Locations (78)

Unknown

Trial Tech Tecnologia em Pesquisa com Medicamentos, Curitiba

Hospital Universitario Walter Cantidio, Fortaleza

Clinilive - Centro de Pesquisas Clinicas, Maringá

Hospital das Clinicas de Porto Alegre, Porto Alegre

Hospital Oswaldo Cruz, Recife

Instituto Américo Bairral de Psiquiatria, Centro de Pesquisa, São Paulo

UNIFESP - Universidade Federal de Sao Paulo, São Paulo

UMHAT Sveti Georgi, Plovdiv

Medical University of Sofia, Aleksandrovska hospital, Sofia

National Hospital of Cardiology, Sofia

University Hospital Sveti Naum, Clinic of Neurology, Sofia

MHAT Sveta Marina, Varna

Clínica Oriente, Antofagasta

Biomedica Research Group, Santiago

Especialidades Medicas LYS, Santiago

Hospital Santiago Oriente, Santiago

Private practice, Santiago

Saint Anne s.r.o. Psychiatricka ambulance, Brno

Brain-Soultherapy s.r.o., Kladno

Bialbi s.r.o., Litoměřice

AD71 s.r.o. Psychiatricka ambulance - Sudkova, Prague

CLINTRIAL s.r.o., Prague

FORBELI s.r.o., Neurologicka ambulance, Prague

Klinikum Altenburger Land GmbH Neurologische Klinik, Altenburg

Neuropsychiatrisches Facharztzentrum Stiepel, Bochum

Universitaetsklinikum des Saarlandes, Klinik für Psychiatrie und Psychotherapie, Homburg / Saar

ISPG Institut für Studien zur Psychischen Gesundheit, Mannheim

Pharmakologisches Studienzentrum Chemnitz GmbH, Mittweida

Somni Bene, Institut fuer Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin

Universitaetsklinik ULM, Poliklinik Neurologie, Ulm

Private practice, Westerstede

Semmelweis Egyetem Neurologiai Klinika, Budapest

Kenezy Gyula Korhaz es Rendelointezet, Debrecen

Vaszary Kolos Korhaz Esztergom Neurologiai Osztaly, Esztergom

Petz Aladar Megyei Oktato Korhaz Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly, Győr

Private practice, Kalocsa

B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly, Miskolc

Josa Andras Oktatokorhaz Pszihiatriai Osztaly, Nyíregyháza

Pecsi Tudomanyegyetem, Klinikai Kozpont Pszich. es Pszichoter. Klinika, Pécs

Szent-Gyorgyi Albert Klinikai Kozpont Pszichiatriai Klinika, Szeged

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Pszichiatriai Osztaly, Székesfehérvár

Memory Clinic Ochanomizu, Bunkyō City

Showakai Clinic, Kagoshima

Rainbow & Sea Hospital, Karatsu-shi

Kokan Clinic, Kawasaki-shi

Social Medical Corporation Kojunkai Daido Hospital, Nagoya

Nakano General Hospital, Nakano

Private practice, Saitama-shi

Private practice, Setagaya-ku

Seishinkai Okehazama Hospital, Toyoake-shi

Instituto Biomedico de Investigacion, Aguascalientes

Centro de Estudios Clinicos Y Especialidades Medicas Sc, Monterrey

Hospital Universitario de Nuevo León, Nuevo León

University Hospital of Saltillo, Saltillo

Nzoz Centrum Kultury, Higieny I Zdrowia Psychicznego, Bydgoszcz

Krakowska Akademia Neurologii Centrum Neurologii Klinicznej, Krakow

NZOZ Neuromed M. i M. Nastaj Sp. Partnerska, Lublin

SENIOR Poradnia Psychogeriatryczna, Sopot

Osrodek Alzheimerowski Sp. z o.o., Ścinawa

Centrum Medyczne Neuroprotect, Warsaw

Interregional Clinico-Diagnostical Centre, Kazan'

First Moscow State Medical University n.a.I.M. Sechenov Clinic of Neurology, Moscow

Scientific Center of Mental Health Sect of AD and associated disord. Dpt of gerontopsychiatry, Moscow

Scientific Center of Mental Health Sect of psychosis of elderly ages Dpt of gerontopsychiatry, Moscow

City geriatric medico-social centre, Saint Petersburg

Medical Military Academy n.a.S.M.Kirov, Saint Petersburg

Psychoneuropathology Dispensary N 10, Saint Petersburg

"Co Ltd LION-MED", Voronezh

Private practice, Bratislava

INVESTA, spol. s r. o. Psychiatricka ambulancia, Košice

NsP Svatej Barbory Psychiatricke oddelenie, Rožňava

Iatros International, Bloemfontein

Flexivest Fourteen Research Centre, Cape Town

Umhlanga Hospital, Durban

Excellentis Clinical Trial Consultants, George

Apollo Clinical Research, Johannesburg

Denmar Hospital, Pretoria

Somerset West Trial Centre, Somerset West

All Listed Sponsors
lead

Institut de Recherches Internationales Servier

OTHER

NCT02626572 - Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms | Biotech Hunter | Biotech Hunter