NCT02648906Unknown4 期
A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- change of ADAS-cog score compared with Baseline
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer patients
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 56 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •56~90 male and female
- •Mini-Mental State Evaluation (MMSE) between 24 and 12
- •Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI
- •Score 0.5, 1, 2 at CDR
- •presence of at least two of the following vascular risk factors: hypertension, diabetes, obesity, ischemic heart disease, dyslipidemia, hyperhomocysteinemia, smoking, previous cerebrovascular events and familiar history of cardio-cerebrovascular diseases.
- •donepezil 10mg from 3 months ago, dose not changed during clinical trials
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
排除标准
- •Subjects allergic to or sensitive to the Investigational Product or applicable ingredients
- •subject who has taken below medication 1 month before screening 1) Cholinesterase Inhibitors 2) NMDA receptor antagonists 3) blood circulation supplements 4) Acetyl-L-Carnitines 5) Nicergoline 6) Subject who has taken another medication that can affect the result of primary outcome
- •subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc.
- •Asthma, COPD
- •Decompensated heart disease
- •Chronic renal failure or chronic liver disease
- •Malignant tumor
- •Subject that cant' be followed up for 12 months after Investigational drug was taken.
- •9 Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods
- •Subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator
研究组 & 干预措施
Choline alfoscerate
Experimental
Drug: Choline alfoscerate and Donepezil
concomitant administration
干预措施: Choline alfoscerate (Drug)
Placebo
Placebo Comparator
Drug: Donepezil only
干预措施: Placebo (Drug)
结局指标
主要结局
change of ADAS-cog score compared with Baseline
时间窗: 48 weeks
Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.
次要结局
未报告次要终点
研究者
研究点 (1)
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