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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

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ClinicalTrials.gov Identifier: NCT02626572
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: S47445 5mg Drug: S47445 15mg Drug: S47445 50mg Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: S47445 5mg 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).
Experimental: S47445 15mg 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).
Experimental: S47445 50mg 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).
Placebo Comparator: Placebo 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).


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline on 11-item ADAS-Cog [ Time Frame: 24 weeks of treatment ]
    Cognition criterion


Secondary Outcome Measures :
  1. Activities of Daily Living: Disability Assessment for Dementia (DAD) [ Time Frame: baseline, week 12, week 24 and week 52 ]
    Key secondary efficacy criterion

  2. Cognition: 13-item ADAS-Cog [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Other secondary efficacy criteria

  3. Cognition: Mini-Mental State Examination (MMSE) [ Time Frame: baseline, week 12, week 24 and week 52 ]
    Other secondary efficacy criteria

  4. Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Other secondary efficacy criteria

  5. Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI) [ Time Frame: baseline, week 4, week 12, week 24 and week 52 ]
    Other secondary efficacy criteria

  6. Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: baseline, week 24 and week 52 ]
    Other secondary efficacy criteria

  7. Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds) [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Other secondary efficacy criteria

  8. Adverse events [ Time Frame: through study completion, an average of 1 year ]
    Safety criterion

  9. Vital signs: heart rate [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Safety criterion

  10. Vital signs: body temperature [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Safety criterion

  11. Vital signs: blood pressure [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Safety criterion

  12. Vital signs: body weight [ Time Frame: baseline, week 12, week 24, week 38 and week 52 ]
    Safety criterion

  13. 12-lead ECG [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Safety criterion

  14. Biological laboratory parameters: number of participants with abnomal laboratory values [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ]
    Safety criterion

  15. Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16) [ Time Frame: baseline, week 4, week 12, week 24, week 28, week 38 and week 52 ]
    Safety criterion


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626572


Locations
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Sponsors and Collaborators
Institut de Recherches Internationales Servier
More Information
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Additional Information:

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02626572    
Other Study ID Numbers: CL2-47445-011
2014-001519-38 ( EudraCT Number )
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://clinicaltrials.servier.com
Additional relevant MeSH terms:
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Alzheimer Disease
Depression
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms