NCT02626572已完成2 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 73
- 主要终点
- Change from baseline on 11-item ADAS-Cog
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
S47445 5mg
Experimental
干预措施: S47445 5mg (Drug)
S47445 15mg
Experimental
干预措施: S47445 15mg (Drug)
S47445 50mg
Experimental
干预措施: S47445 50mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline on 11-item ADAS-Cog
时间窗: 24 weeks of treatment
Cognition criterion
次要结局
- Cognition: 13-item ADAS-Cog(baseline, week 4, week 12, week 24, week 38 and week 52)
- Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)(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)(baseline, week 24 and week 52)
- Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds)(baseline, week 4, week 12, week 24, week 38 and week 52)
- Vital signs: heart rate(baseline, week 4, week 12, week 24, week 38 and week 52)
- 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)
- Vital signs: body weight(baseline, week 12, week 24, week 38 and week 52)
- Activities of Daily Living: Disability Assessment for Dementia (DAD)(baseline, week 12, week 24 and week 52)
- Adverse events(through study completion, an average of 1 year)
- Vital signs: body temperature(baseline, week 4, week 12, week 24, week 38 and week 52)
- Biological laboratory parameters: number of participants with abnomal laboratory values(baseline, week 4, week 12, week 24, week 38 and week 52)
- Cognition: Mini-Mental State Examination (MMSE)(baseline, week 12, week 24 and week 52)
- Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)(baseline, week 4, week 12, week 24, week 38 and week 52)
- Vital signs: blood pressure(baseline, week 4, week 12, week 24, week 38 and week 52)
- 12-lead ECG(baseline, week 4, week 12, week 24, week 38 and week 52)
研究者
研究点 (73)
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