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Alzheimer's DiseasePhase 2NCT02626572

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 Phase 2 study testing S47445 5mg, S47445 15mg and S47445 50mg in people with Alzheimer's Disease, run by Institut de Recherches Internationales Servier at 78 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
S47445 5mg, S47445 15mg and S47445 50mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
78 sitesin 12 countries
Study dates
Feb 2015to Sep 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

78 sites in 12 countries.

78 sites in 12 countries

Hungary10 sites

  • 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

Other trials in Hungary

Japan9 sites

  • 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

Other trials in Japan

Germany8 sites

  • 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

Other trials in Germany

Russia8 sites

  • 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

Other trials in Russia

Brazil7 sites

  • 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

Other trials in Brazil

South Africa7 sites

  • 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

Other trials in South Africa

Czechia6 sites

  • 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

Other trials in Czechia

Poland6 sites

  • Nzoz Centrum Kultury, Higieny I Zdrowia Psychicznego

    Bydgoszcz

  • Krakowska Akademia Neurologii Centrum Neurologii Klinicznej

    Krakow

  • NZOZ Neuromed M. i M. Nastaj Sp. Partnerska

    Lublin

  • Osrodek Alzheimerowski Sp. z o.o.

    Ścinawa

  • SENIOR Poradnia Psychogeriatryczna

    Sopot

  • Centrum Medyczne Neuroprotect

    Warsaw

Other trials in Poland

Bulgaria5 sites

  • 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

Other trials in Bulgaria

Chile5 sites

  • Clínica Oriente

    Antofagasta

  • Biomedica Research Group

    Santiago

  • Especialidades Medicas LYS

    Santiago

  • Hospital Santiago Oriente

    Santiago

  • Private practice

    Santiago

Other trials in Chile

Mexico4 sites

  • 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

Other trials in Mexico

Slovakia3 sites

  • Private practice

    Bratislava

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

    Košice

  • NsP Svatej Barbory Psychiatricke oddelenie

    Rožňava

Other trials in Slovakia

About this study

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.

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.

Being tested
S47445 5mg, S47445 15mg, S47445 50mg, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S47445 5mgDrug

    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 15mgDrug

    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 50mgDrug

    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).

  • PlaceboDrug

    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).

Study groups in NCT02626572
Study groupRoleWhat they receive
S47445 5mgExperimentalNot described
Receives: Drug: S47445 5mg
S47445 15mgExperimentalNot described
Receives: Drug: S47445 15mg
S47445 50mgExperimentalNot described
Receives: Drug: S47445 50mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline on 11-item ADAS-Cog

    Cognition criterion

    Measured: 24 weeks of treatment

Secondary outcomes (15)

  1. Activities of Daily Living: Disability Assessment for Dementia (DAD)

    Key secondary efficacy criterion

    Measured: baseline, week 12, week 24 and week 52

  2. Cognition: 13-item ADAS-Cog

    Other secondary efficacy criteria

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  3. Cognition: Mini-Mental State Examination (MMSE)

    Other secondary efficacy criteria

    Measured: baseline, week 12, week 24 and week 52

  4. Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)

    Other secondary efficacy criteria

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  5. Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)

    Other secondary efficacy criteria

    Measured: baseline, week 4, week 12, week 24 and week 52

  6. Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC)

    Other secondary efficacy criteria

    Measured: baseline, week 24 and week 52

  7. Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds)

    Other secondary efficacy criteria

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  8. Adverse events

    Safety criterion

    Measured: through study completion, an average of 1 year

  9. Vital signs: heart rate

    Safety criterion

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  10. Vital signs: body temperature

    Safety criterion

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  11. Vital signs: blood pressure

    Safety criterion

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  12. Vital signs: body weight

    Safety criterion

    Measured: baseline, week 12, week 24, week 38 and week 52

  13. 12-lead ECG

    Safety criterion

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  14. Biological laboratory parameters: number of participants with abnomal laboratory values

    Safety criterion

    Measured: baseline, week 4, week 12, week 24, week 38 and week 52

  15. Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16)

    Safety criterion

    Measured: baseline, week 4, week 12, week 24, week 28, week 38 and week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02626572
Sponsor's protocol ID
CL2-47445-011
Other IDs
2014-001519-38, 2014
Status last verified
Jul 2024
First submitted
4 Nov 2015
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 31297437

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S47445 5mg, S47445 15mg and S47445 50mg in people with Alzheimer's Disease, run by Institut de Recherches Internationales Servier at 78 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Hungary, Japan, Germany, Russia, Brazil and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline on 11-item ADAS-Cog (time frame: 24 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02626572, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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