Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms
2 other identifiers
interventional
500
12 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2015
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJuly 25, 2024
July 1, 2024
2.6 years
November 4, 2015
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline on 11-item ADAS-Cog
Cognition criterion
24 weeks of treatment
Secondary Outcomes (15)
Activities of Daily Living: Disability Assessment for Dementia (DAD)
baseline, week 12, week 24 and week 52
Cognition: 13-item ADAS-Cog
baseline, week 4, week 12, week 24, week 38 and week 52
Cognition: Mini-Mental State Examination (MMSE)
baseline, week 12, week 24 and week 52
Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)
baseline, week 4, week 12, week 24, week 38 and week 52
Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)
baseline, week 4, week 12, week 24 and week 52
- +10 more secondary outcomes
Study Arms (4)
S47445 5mg
EXPERIMENTALS47445 15mg
EXPERIMENTALS47445 50mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 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 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 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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (1)
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.
PMID: 31297437RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2015
First Posted
December 10, 2015
Study Start
February 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
July 25, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.