Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: S47445 5mgDrug: S47445 15mgDrug: S47445 50mgDrug: Placebo
- Registration Number
- NCT02626572
- Lead Sponsor
- Institut de Recherches Internationales Servier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S47445 5mg S47445 5mg - S47445 15mg S47445 15mg - S47445 50mg S47445 50mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline on 11-item ADAS-Cog 24 weeks of treatment Cognition criterion
- Secondary Outcome Measures
Name Time Method Cognition: 13-item ADAS-Cog baseline, week 4, week 12, week 24, week 38 and week 52 Other secondary efficacy criteria
Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI) baseline, week 4, week 12, week 24 and week 52 Other secondary efficacy criteria
Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC) baseline, week 24 and week 52 Other secondary efficacy criteria
Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds) baseline, week 4, week 12, week 24, week 38 and week 52 Other secondary efficacy criteria
Vital signs: heart rate baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16) baseline, week 4, week 12, week 24, week 28, week 38 and week 52 Safety criterion
Vital signs: body weight baseline, week 12, week 24, week 38 and week 52 Safety criterion
Adverse events through study completion, an average of 1 year Safety criterion
Vital signs: body temperature baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Biological laboratory parameters: number of participants with abnomal laboratory values baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Activities of Daily Living: Disability Assessment for Dementia (DAD) baseline, week 12, week 24 and week 52 Key secondary efficacy criterion
Cognition: Mini-Mental State Examination (MMSE) baseline, week 12, week 24 and week 52 Other secondary efficacy criteria
Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD) baseline, week 4, week 12, week 24, week 38 and week 52 Other secondary efficacy criteria
Vital signs: blood pressure baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
12-lead ECG baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Trial Locations
- Locations (73)
Centro de Estudios Clinicos Y Especialidades Medicas Sc
🇲🇽Monterrey, Mexico
Nzoz Centrum Kultury, Higieny I Zdrowia Psychicznego
🇵🇱Bydgoszcz, Poland
Osrodek Alzheimerowski Sp. z o.o.
🇵🇱Scinawa, Poland
Private practice
🇸🇰Bratislava, Slovakia
Hospital Oswaldo Cruz
🇧🇷Recife, Brazil
Hospital Universitario Walter Cantidio
🇧🇷Fortaleza, Brazil
Trial Tech Tecnologia em Pesquisa com Medicamentos
🇧🇷Curitiba, Brazil
Hospital das Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Clinilive - Centro de Pesquisas Clinicas
🇧🇷Maringa, Brazil
UNIFESP - Universidade Federal de Sao Paulo
🇧🇷Sao Paulo, Brazil
Medical University of Sofia, Aleksandrovska hospital
🇧🇬Sofia, Bulgaria
Instituto Américo Bairral de Psiquiatria, Centro de Pesquisa
🇧🇷Sao Paulo, Brazil
UMHAT Sveti Georgi
🇧🇬Plovdiv, Bulgaria
National Hospital of Cardiology
🇧🇬Sofia, Bulgaria
University Hospital Sveti Naum, Clinic of Neurology
🇧🇬Sofia, Bulgaria
MHAT Sveta Marina
🇧🇬Varna, Bulgaria
ClÃnica Oriente
🇨🇱Antofagasta, Chile
Biomedica Research Group
🇨🇱Santiago, Chile
Especialidades Medicas LYS
🇨🇱Santiago, Chile
Hospital Santiago Oriente
🇨🇱Santiago, Chile
Saint Anne s.r.o. Psychiatricka ambulance
🇨🇿Brno, Czechia
Bialbi s.r.o.
🇨🇿Litomerice, Czechia
Brain-Soultherapy s.r.o.
🇨🇿Kladno, Czechia
CLINTRIAL s.r.o.
🇨🇿Praha, Czechia
Neuropsychiatrisches Facharztzentrum Stiepel
🇩🇪Bochum, 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
Semmelweis Egyetem Neurologiai Klinika
ðŸ‡ðŸ‡ºBudapest, Hungary
Vaszary Kolos Korhaz Esztergom Neurologiai Osztaly
ðŸ‡ðŸ‡ºEsztergom, Hungary
Kenezy Gyula Korhaz es Rendelointezet
ðŸ‡ðŸ‡ºDebrecen, Hungary
Petz Aladar Megyei Oktato Korhaz Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
ðŸ‡ðŸ‡ºGyor, Hungary
B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly
ðŸ‡ðŸ‡ºMiskolc, Hungary
Josa Andras Oktatokorhaz Pszihiatriai Osztaly
ðŸ‡ðŸ‡ºNyiregyhaza, Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont Pszich. es Pszichoter. Klinika
ðŸ‡ðŸ‡ºPecs, Hungary
Szent-Gyorgyi Albert Klinikai Kozpont Pszichiatriai Klinika
ðŸ‡ðŸ‡ºSzeged, Hungary
Memory Clinic Ochanomizu
🇯🇵Bunkyo-ku, Japan
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Pszichiatriai Osztaly
ðŸ‡ðŸ‡ºSzekesfehervar, Hungary
Showakai Clinic
🇯🇵Kagoshima-shi, Japan
Rainbow & Sea Hospital
🇯🇵Karatsu-shi, Japan
Kokan Clinic
🇯🇵Kawasaki-shi, Japan
Nakano General Hospital
🇯🇵Nakano-ku, Japan
Seishinkai Okehazama Hospital
🇯🇵Toyoake-shi, Japan
Instituto Biomedico de Investigacion
🇲🇽Aguascalientes, Mexico
University Hospital of Saltillo
🇲🇽Saltillo, Mexico
Hospital Universitario de Nuevo León
🇲🇽Nuevo León, Mexico
Krakowska Akademia Neurologii Centrum Neurologii Klinicznej
🇵🇱Krakow, Poland
NZOZ Neuromed M. i M. Nastaj Sp. Partnerska
🇵🇱Lublin, Poland
SENIOR Poradnia Psychogeriatryczna
🇵🇱Sopot, Poland
Centrum Medyczne Neuroprotect
🇵🇱Warszawa, Poland
Interregional Clinico-Diagnostical Centre
🇷🇺Kazan, Russian Federation
First Moscow State Medical University n.a.I.M. Sechenov Clinic of Neurology
🇷🇺Moscow, Russian Federation
Scientific Center of Mental Health Sect of AD and associated disord. Dpt of gerontopsychiatry
🇷🇺Moscow, Russian Federation
Scientific Center of Mental Health Sect of psychosis of elderly ages Dpt of gerontopsychiatry
🇷🇺Moscow, Russian Federation
City geriatric medico-social centre
🇷🇺St. Petersburg, Russian Federation
Medical Military Academy n.a.S.M.Kirov
🇷🇺St. Petersburg, Russian Federation
Psychoneuropathology Dispensary N 10
🇷🇺St. Petersburg, Russian Federation
Co Ltd "LION-MED"
🇷🇺Voronezh, Russian Federation
INVESTA, spol. s r. o. Psychiatricka ambulancia
🇸🇰Kosice, Slovakia
NsP Svatej Barbory Psychiatricke oddelenie
🇸🇰Roznava, Slovakia
Flexivest Fourteen Research Centre
🇿🇦Cape Town, South Africa
Apollo Clinical Research
🇿🇦Johannesburg, South Africa
Umhlanga Hospital
🇿🇦Durban, South Africa
Excellentis Clinical Trial Consultants
🇿🇦George, South Africa
Denmar Hospital
🇿🇦Pretoria, South Africa
Somerset West Trial Centre
🇿🇦Somerset West, South Africa
Klinikum Altenburger Land GmbH Neurologische Klinik
🇩🇪Altenburg, Germany
FORBELI s.r.o., Neurologicka ambulance
🇨🇿Praha, Czechia
Social Medical Corporation Kojunkai Daido Hospital
🇯🇵Nagoya, Japan
AD71 s.r.o. Psychiatricka ambulance - Sudkova
🇨🇿Praha, Czechia
Universitaetsklinikum des Saarlandes, Klinik für Psychiatrie und Psychotherapie
🇩🇪Homburg / Saar, Germany
Iatros International
🇿🇦Bloemfontein, South Africa