NCT04346862Unknown4 期
Phase IV Study to Evaluate the Effect of Improvement in Cognitive Impairment of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 636 人开始时间: 2016年1月26日最近更新:
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
- 636
- 试验地点
- 1
- 主要终点
- Interference score using K-CWST(Korean-Color Word Stroop Test)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Acetyl-L-carnitine in patient with Mild Cognitive Impairment associated with chronic cerebrovascular disease.
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
- •Age between 55 and 85 years old
- •Patients with chronic cerebrovascular disease, who have modified Fazekas scale grade 2 ~ 3
- •Patients wtih a diagnosis of MCI
- •MOCA-K of 23 or less
- •Patients who provided a signed written informed consent form
排除标准
- •Patiens who are uneducated or illiterate
- •Patiens previously treated with dementia
- •Patients who received a nootropic agent or thyroid hormone within 4 weeks of visit 1
- •Patients with cognitive impairment due to diseases other than cerebrovascular disease
- •Patients with severe depression, schizophrenia, alcoholism, and drug dependence
研究组 & 干预措施
Acetyl-L-carnitine hydrochloride
Experimental
干预措施: Acetyl-L-carnitine hydrochloride 500mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Interference score using K-CWST(Korean-Color Word Stroop Test)
时间窗: 24 week
interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word)
Montreal Cognitive Assessment Korean(MOCA-K)
时间窗: 24 week
MOCA-K included cognitive domains; attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. MOCA-K scored from 0 to 30. The higher the score, the better.
次要结局
- Clinical Global Impression -Improvement (CGI-I)(24 week)
- Korean Trail Making Test Elderly(K-TMT-e)(24 week)
- EQ-5D(24 week)
研究者
研究点 (1)
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