A Phase 2 interventional study of S47445 5mg and S47445 15mg in Alzheimer's Disease, sponsored by Institut de Recherches Internationales Servier. Completed at 78 sites in 12 countries. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Institut de Recherches Internationales Servier · Phase 2, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 500 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Institut de Recherches Internationales Servier is the lead sponsor of 64 studies on the registry; 5 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: S47445 5mg
Drug: S47445 15mg
Drug: S47445 50mg
Drug: Placebo
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).
Change from baseline on 11-item ADAS-Cog
Cognition criterion
Time frame: 24 weeks of treatment
Activities of Daily Living: Disability Assessment for Dementia (DAD)
Key secondary efficacy criterion
Time frame: baseline, week 12, week 24 and week 52
Cognition: 13-item ADAS-Cog
Other secondary efficacy criteria
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Cognition: Mini-Mental State Examination (MMSE)
Other secondary efficacy criteria
Time frame: baseline, week 12, week 24 and week 52
Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)
Other secondary efficacy criteria
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)
Other secondary efficacy criteria
Time frame: baseline, week 4, week 12, week 24 and week 52
Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC)
Other secondary efficacy criteria
Time frame: baseline, week 24 and week 52
Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds)
Other secondary efficacy criteria
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Adverse events
Safety criterion
Time frame: through study completion, an average of 1 year
Vital signs: heart rate
Safety criterion
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Vital signs: body temperature
Safety criterion
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Vital signs: blood pressure
Safety criterion
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Vital signs: body weight
Safety criterion
Time frame: baseline, week 12, week 24, week 38 and week 52
12-lead ECG
Safety criterion
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Biological laboratory parameters: number of participants with abnomal laboratory values
Safety criterion
Time frame: baseline, week 4, week 12, week 24, week 38 and week 52
Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16)
Safety criterion
Time frame: baseline, week 4, week 12, week 24, week 28, week 38 and week 52
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Internationales Servier