NCT05050604尚未招募4 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Mild Cognitive Impairment Patients With Cerebrovascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease
详细描述
Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment
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)
盲法说明
Double Blind (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Patients with vascular cognitive impairment according to modified Fazekas scale grade 2~3 and/or more than 3 of lacunar infarction in Supratentorial
- •Patients with Clinical Deterioration Rating(CDR) score of 0.5
- •Patients with Korean-Montreal Cognitive Assessment (K-MoCA) score of 23 or less
- •Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
- •Written informed consent
排除标准
- •Clinical diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis), Creutzfeld-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)
- •Medication of dementia within the past 3 months. (e.g., donepezil, galantamine, rivastigmine, memantine)
- •Medication of brain functional improvement medication within the past 6 weeks. (e.g., citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine)
- •No studies (no regular school entrance), illiteracy
- •Stroke within the past 3 months
- •Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject
- •Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
- •Severe cardiovascular disease such as myocardial infarction, unstable angina or heart failure within the past 6 months
研究组 & 干预措施
Choline Alfoscerate
Experimental
干预措施: Choline Alfoscerate 400mg (Drug)
Placebo of Choline Alfoscerate
Placebo Comparator
干预措施: Placebo of Choline Alfoscerate 400mg (Drug)
结局指标
主要结局
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
时间窗: Baseline to 48 weeks
次要结局
- The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline(Baseline, 24 weeks, 48 weeks)
- The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline(Baseline to 24 weeks)
- The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The change of CDR-SB score at 48 weeks compared to baseline(Baseline to 48 weeks)
- The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
- The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
研究者
研究点 (1)
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