Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: S47445 5mgDrug: S47445 15mgDrug: S47445 50mgDrug: Placebo
- Registration Number
- NCT02626572
- Lead Sponsor
- Institut de Recherches Internationales Servier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S47445 5mg S47445 5mg - S47445 15mg S47445 15mg - S47445 50mg S47445 50mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline on 11-item ADAS-Cog 24 weeks of treatment Cognition criterion
- Secondary Outcome Measures
Name Time Method Cognition: 13-item ADAS-Cog baseline, week 4, week 12, week 24, week 38 and week 52 Other secondary efficacy criteria
Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI) baseline, week 4, week 12, week 24 and week 52 Other secondary efficacy criteria
Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC) baseline, week 24 and week 52 Other secondary efficacy criteria
Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds) baseline, week 4, week 12, week 24, week 38 and week 52 Other secondary efficacy criteria
Vital signs: heart rate baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16) baseline, week 4, week 12, week 24, week 28, week 38 and week 52 Safety criterion
Vital signs: body weight baseline, week 12, week 24, week 38 and week 52 Safety criterion
Adverse events through study completion, an average of 1 year Safety criterion
Vital signs: body temperature baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Biological laboratory parameters: number of participants with abnomal laboratory values baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Activities of Daily Living: Disability Assessment for Dementia (DAD) baseline, week 12, week 24 and week 52 Key secondary efficacy criterion
Cognition: Mini-Mental State Examination (MMSE) baseline, week 12, week 24 and week 52 Other secondary efficacy criteria
Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD) baseline, week 4, week 12, week 24, week 38 and week 52 Other secondary efficacy criteria
Vital signs: blood pressure baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
12-lead ECG baseline, week 4, week 12, week 24, week 38 and week 52 Safety criterion
Trial Locations
- Locations (73)
Trial Tech Tecnologia em Pesquisa com Medicamentos
🇧🇷Curitiba, Brazil
Hospital Universitario Walter Cantidio
🇧🇷Fortaleza, Brazil
Clinilive - Centro de Pesquisas Clinicas
🇧🇷Maringa, Brazil
Hospital das Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Hospital Oswaldo Cruz
🇧🇷Recife, Brazil
Instituto Américo Bairral de Psiquiatria, Centro de Pesquisa
🇧🇷Sao Paulo, Brazil
UNIFESP - Universidade Federal de Sao Paulo
🇧🇷Sao Paulo, Brazil
UMHAT Sveti Georgi
🇧🇬Plovdiv, Bulgaria
Medical University of Sofia, Aleksandrovska hospital
🇧🇬Sofia, Bulgaria
National Hospital of Cardiology
🇧🇬Sofia, Bulgaria
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