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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
S47445 5mg
S47445 15mg
S47445 50mg
Placebo
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trial Tech Tecnologia em Pesquisa com Medicamentos
  • Hospital Universitario Walter Cantidio
  • Clinilive - Centro de Pesquisas Clinicas
  • Hospital das Clinicas de Porto Alegre
  • Hospital Oswaldo Cruz
  • Instituto Américo Bairral de Psiquiatria, Centro de Pesquisa
  • UNIFESP - Universidade Federal de Sao Paulo
  • UMHAT Sveti Georgi
  • Medical University of Sofia, Aleksandrovska hospital
  • National Hospital of Cardiology
  • University Hospital Sveti Naum, Clinic of Neurology
  • MHAT Sveta Marina
  • Clínica Oriente
  • Biomedica Research Group
  • Especialidades Medicas LYS
  • Hospital Santiago Oriente
  • Private practice
  • Saint Anne s.r.o. Psychiatricka ambulance
  • Brain-Soultherapy s.r.o.
  • Bialbi s.r.o.
  • AD71 s.r.o. Psychiatricka ambulance - Sudkova
  • CLINTRIAL s.r.o.
  • FORBELI s.r.o., Neurologicka ambulance
  • Klinikum Altenburger Land GmbH Neurologische Klinik
  • Neuropsychiatrisches Facharztzentrum Stiepel
  • Universitaetsklinikum des Saarlandes, Klinik für Psychiatrie und Psychotherapie
  • ISPG Institut für Studien zur Psychischen Gesundheit
  • Pharmakologisches Studienzentrum Chemnitz GmbH
  • Somni Bene, Institut fuer Medizinische Forschung und Schlafmedizin Schwerin GmbH
  • Universitaetsklinik ULM, Poliklinik Neurologie
  • Private practice
  • Semmelweis Egyetem Neurologiai Klinika
  • Kenezy Gyula Korhaz es Rendelointezet
  • Vaszary Kolos Korhaz Esztergom Neurologiai Osztaly
  • Petz Aladar Megyei Oktato Korhaz Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
  • Private practice
  • B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly
  • Josa Andras Oktatokorhaz Pszihiatriai Osztaly
  • Pecsi Tudomanyegyetem, Klinikai Kozpont Pszich. es Pszichoter. Klinika
  • Szent-Gyorgyi Albert Klinikai Kozpont Pszichiatriai Klinika
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Pszichiatriai Osztaly
  • Memory Clinic Ochanomizu
  • Showakai Clinic
  • Rainbow & Sea Hospital
  • Kokan Clinic
  • Social Medical Corporation Kojunkai Daido Hospital
  • Nakano General Hospital
  • Private practice
  • Private practice
  • Seishinkai Okehazama Hospital
  • Instituto Biomedico de Investigacion
  • Centro de Estudios Clinicos Y Especialidades Medicas Sc
  • Hospital Universitario de Nuevo León
  • University Hospital of Saltillo
  • Nzoz Centrum Kultury, Higieny I Zdrowia Psychicznego
  • Krakowska Akademia Neurologii Centrum Neurologii Klinicznej
  • NZOZ Neuromed M. i M. Nastaj Sp. Partnerska
  • Osrodek Alzheimerowski Sp. z o.o.
  • SENIOR Poradnia Psychogeriatryczna
  • Centrum Medyczne Neuroprotect
  • Interregional Clinico-Diagnostical Centre
  • First Moscow State Medical University n.a.I.M. Sechenov Clinic of Neurology
  • Scientific Center of Mental Health Sect of AD and associated disord. Dpt of gerontopsychiatry
  • Scientific Center of Mental Health Sect of psychosis of elderly ages Dpt of gerontopsychiatry
  • City geriatric medico-social centre
  • Medical Military Academy n.a.S.M.Kirov
  • Psychoneuropathology Dispensary N 10
  • Co Ltd "LION-MED"
  • Private practice
  • INVESTA, spol. s r. o. Psychiatricka ambulancia
  • NsP Svatej Barbory Psychiatricke oddelenie
  • Iatros International
  • Flexivest Fourteen Research Centre
  • Umhlanga Hospital
  • Excellentis Clinical Trial Consultants
  • Apollo Clinical Research
  • Denmar Hospital
  • Somerset West Trial Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

S47445 5mg

S47445 15mg

S47445 50mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline on 11-item ADAS-Cog
Cognition criterion

Secondary Outcome Measures

Activities of Daily Living: Disability Assessment for Dementia (DAD)
Key secondary efficacy criterion
Cognition: 13-item ADAS-Cog
Other secondary efficacy criteria
Cognition: Mini-Mental State Examination (MMSE)
Other secondary efficacy criteria
Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)
Other secondary efficacy criteria
Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)
Other secondary efficacy criteria
Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC)
Other secondary efficacy criteria
Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds)
Other secondary efficacy criteria
Adverse events
Safety criterion
Vital signs: heart rate
Safety criterion
Vital signs: body temperature
Safety criterion
Vital signs: blood pressure
Safety criterion
Vital signs: body weight
Safety criterion
12-lead ECG
Safety criterion
Biological laboratory parameters: number of participants with abnomal laboratory values
Safety criterion
Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16)
Safety criterion

Full Information

First Posted
November 4, 2015
Last Updated
August 13, 2018
Sponsor
Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT02626572
Brief 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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S47445 5mg
Arm Type
Experimental
Arm Title
S47445 15mg
Arm Type
Experimental
Arm Title
S47445 50mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
S47445 5mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
S47445 15mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
S47445 50mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline on 11-item ADAS-Cog
Description
Cognition criterion
Time Frame
24 weeks of treatment
Secondary Outcome Measure Information:
Title
Activities of Daily Living: Disability Assessment for Dementia (DAD)
Description
Key secondary efficacy criterion
Time Frame
baseline, week 12, week 24 and week 52
Title
Cognition: 13-item ADAS-Cog
Description
Other secondary efficacy criteria
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Cognition: Mini-Mental State Examination (MMSE)
Description
Other secondary efficacy criteria
Time Frame
baseline, week 12, week 24 and week 52
Title
Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)
Description
Other secondary efficacy criteria
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)
Description
Other secondary efficacy criteria
Time Frame
baseline, week 4, week 12, week 24 and week 52
Title
Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC)
Description
Other secondary efficacy criteria
Time Frame
baseline, week 24 and week 52
Title
Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds)
Description
Other secondary efficacy criteria
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Adverse events
Description
Safety criterion
Time Frame
through study completion, an average of 1 year
Title
Vital signs: heart rate
Description
Safety criterion
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Vital signs: body temperature
Description
Safety criterion
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Vital signs: blood pressure
Description
Safety criterion
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Vital signs: body weight
Description
Safety criterion
Time Frame
baseline, week 12, week 24, week 38 and week 52
Title
12-lead ECG
Description
Safety criterion
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Biological laboratory parameters: number of participants with abnomal laboratory values
Description
Safety criterion
Time Frame
baseline, week 4, week 12, week 24, week 38 and week 52
Title
Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16)
Description
Safety criterion
Time Frame
baseline, week 4, week 12, week 24, week 28, week 38 and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Trial Tech Tecnologia em Pesquisa com Medicamentos
City
Curitiba
Country
Brazil
Facility Name
Hospital Universitario Walter Cantidio
City
Fortaleza
Country
Brazil
Facility Name
Clinilive - Centro de Pesquisas Clinicas
City
Maringa
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Oswaldo Cruz
City
Recife
Country
Brazil
Facility Name
Instituto Américo Bairral de Psiquiatria, Centro de Pesquisa
City
Sao Paulo
Country
Brazil
Facility Name
UNIFESP - Universidade Federal de Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
UMHAT Sveti Georgi
City
Plovdiv
Country
Bulgaria
Facility Name
Medical University of Sofia, Aleksandrovska hospital
City
Sofia
Country
Bulgaria
Facility Name
National Hospital of Cardiology
City
Sofia
Country
Bulgaria
Facility Name
University Hospital Sveti Naum, Clinic of Neurology
City
Sofia
Country
Bulgaria
Facility Name
MHAT Sveta Marina
City
Varna
Country
Bulgaria
Facility Name
Clínica Oriente
City
Antofagasta
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
Country
Chile
Facility Name
Especialidades Medicas LYS
City
Santiago
Country
Chile
Facility Name
Hospital Santiago Oriente
City
Santiago
Country
Chile
Facility Name
Private practice
City
Santiago
Country
Chile
Facility Name
Saint Anne s.r.o. Psychiatricka ambulance
City
Brno
Country
Czechia
Facility Name
Brain-Soultherapy s.r.o.
City
Kladno
Country
Czechia
Facility Name
Bialbi s.r.o.
City
Litomerice
Country
Czechia
Facility Name
AD71 s.r.o. Psychiatricka ambulance - Sudkova
City
Praha
Country
Czechia
Facility Name
CLINTRIAL s.r.o.
City
Praha
Country
Czechia
Facility Name
FORBELI s.r.o., Neurologicka ambulance
City
Praha
Country
Czechia
Facility Name
Klinikum Altenburger Land GmbH Neurologische Klinik
City
Altenburg
Country
Germany
Facility Name
Neuropsychiatrisches Facharztzentrum Stiepel
City
Bochum
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes, Klinik für Psychiatrie und Psychotherapie
City
Homburg / Saar
Country
Germany
Facility Name
ISPG Institut für Studien zur Psychischen Gesundheit
City
Mannheim
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz GmbH
City
Mittweida
Country
Germany
Facility Name
Somni Bene, Institut fuer Medizinische Forschung und Schlafmedizin Schwerin GmbH
City
Schwerin
Country
Germany
Facility Name
Universitaetsklinik ULM, Poliklinik Neurologie
City
Ulm
Country
Germany
Facility Name
Private practice
City
Westerstede
Country
Germany
Facility Name
Semmelweis Egyetem Neurologiai Klinika
City
Budapest
Country
Hungary
Facility Name
Kenezy Gyula Korhaz es Rendelointezet
City
Debrecen
Country
Hungary
Facility Name
Vaszary Kolos Korhaz Esztergom Neurologiai Osztaly
City
Esztergom
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz Pszihiatriai, Mentalhygienes es Addiktologiai Osztaly
City
Gyor
Country
Hungary
Facility Name
Private practice
City
Kalocsa
Country
Hungary
Facility Name
B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly
City
Miskolc
Country
Hungary
Facility Name
Josa Andras Oktatokorhaz Pszihiatriai Osztaly
City
Nyiregyhaza
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem, Klinikai Kozpont Pszich. es Pszichoter. Klinika
City
Pecs
Country
Hungary
Facility Name
Szent-Gyorgyi Albert Klinikai Kozpont Pszichiatriai Klinika
City
Szeged
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Pszichiatriai Osztaly
City
Szekesfehervar
Country
Hungary
Facility Name
Memory Clinic Ochanomizu
City
Bunkyo-ku
Country
Japan
Facility Name
Showakai Clinic
City
Kagoshima-shi
Country
Japan
Facility Name
Rainbow & Sea Hospital
City
Karatsu-shi
Country
Japan
Facility Name
Kokan Clinic
City
Kawasaki-shi
Country
Japan
Facility Name
Social Medical Corporation Kojunkai Daido Hospital
City
Nagoya
Country
Japan
Facility Name
Nakano General Hospital
City
Nakano-ku
Country
Japan
Facility Name
Private practice
City
Saitama-shi
Country
Japan
Facility Name
Private practice
City
Setagaya-ku
Country
Japan
Facility Name
Seishinkai Okehazama Hospital
City
Toyoake-shi
Country
Japan
Facility Name
Instituto Biomedico de Investigacion
City
Aguascalientes
Country
Mexico
Facility Name
Centro de Estudios Clinicos Y Especialidades Medicas Sc
City
Monterrey
Country
Mexico
Facility Name
Hospital Universitario de Nuevo León
City
Nuevo León
Country
Mexico
Facility Name
University Hospital of Saltillo
City
Saltillo
Country
Mexico
Facility Name
Nzoz Centrum Kultury, Higieny I Zdrowia Psychicznego
City
Bydgoszcz
Country
Poland
Facility Name
Krakowska Akademia Neurologii Centrum Neurologii Klinicznej
City
Krakow
Country
Poland
Facility Name
NZOZ Neuromed M. i M. Nastaj Sp. Partnerska
City
Lublin
Country
Poland
Facility Name
Osrodek Alzheimerowski Sp. z o.o.
City
Scinawa
Country
Poland
Facility Name
SENIOR Poradnia Psychogeriatryczna
City
Sopot
Country
Poland
Facility Name
Centrum Medyczne Neuroprotect
City
Warszawa
Country
Poland
Facility Name
Interregional Clinico-Diagnostical Centre
City
Kazan
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a.I.M. Sechenov Clinic of Neurology
City
Moscow
Country
Russian Federation
Facility Name
Scientific Center of Mental Health Sect of AD and associated disord. Dpt of gerontopsychiatry
City
Moscow
Country
Russian Federation
Facility Name
Scientific Center of Mental Health Sect of psychosis of elderly ages Dpt of gerontopsychiatry
City
Moscow
Country
Russian Federation
Facility Name
City geriatric medico-social centre
City
St. Petersburg
Country
Russian Federation
Facility Name
Medical Military Academy n.a.S.M.Kirov
City
St. Petersburg
Country
Russian Federation
Facility Name
Psychoneuropathology Dispensary N 10
City
St. Petersburg
Country
Russian Federation
Facility Name
Co Ltd "LION-MED"
City
Voronezh
Country
Russian Federation
Facility Name
Private practice
City
Bratislava
Country
Slovakia
Facility Name
INVESTA, spol. s r. o. Psychiatricka ambulancia
City
Kosice
Country
Slovakia
Facility Name
NsP Svatej Barbory Psychiatricke oddelenie
City
Roznava
Country
Slovakia
Facility Name
Iatros International
City
Bloemfontein
Country
South Africa
Facility Name
Flexivest Fourteen Research Centre
City
Cape Town
Country
South Africa
Facility Name
Umhlanga Hospital
City
Durban
Country
South Africa
Facility Name
Excellentis Clinical Trial Consultants
City
George
Country
South Africa
Facility Name
Apollo Clinical Research
City
Johannesburg
Country
South Africa
Facility Name
Denmar Hospital
City
Pretoria
Country
South Africa
Facility Name
Somerset West Trial Centre
City
Somerset West
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing 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.
IPD Sharing URL
http://clinicaltrials.servier.com
Links:
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-47445-011-synopsis-report.pdf
Description
Results summary

Learn more about this trial

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

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