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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
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).
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
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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).
Trial Tech Tecnologia em Pesquisa com Medicamentos
Curitiba, Brazil
Hospital Universitario Walter Cantidio
Fortaleza, Brazil
Clinilive - Centro de Pesquisas Clinicas
Maringá, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, Brazil
Hospital Oswaldo Cruz
Recife, Brazil
Instituto Américo Bairral de Psiquiatria, Centro de Pesquisa
São Paulo, Brazil
UNIFESP - Universidade Federal de Sao Paulo
São Paulo, Brazil
UMHAT Sveti Georgi
Plovdiv, Bulgaria
Medical University of Sofia, Aleksandrovska hospital
Sofia, Bulgaria
National Hospital of Cardiology
Sofia, Bulgaria
...and 68 more locations
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