NCT02955706已完成4 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- ADAS-cog
研究概览
简要总结
clinical trial to assess the efficacy of Acetyl-L-carnitine
详细描述
A multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of Acetyl-L-carnitine in patient with Alzheimer's 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
- Triple (Participant, Care Provider, 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
- •More than 50 Years
- •probable Alzheimer disease according to DSM-IV and NINCDS-ADRDA standard
- •12≤K-MMSE(screening)≤26
- •be able to perform examinations
- •Patient taking donepezil(5mg or 10mg/day) more than 3 months
- •be able to visit to hospital with caregiver
排除标准
- •possible or probable or definite vascular dementia according to NINDS-AIREN standard
- •CNS disease(Cerebrovascular diseases, Epilepsy etc) to cause dementia
- •Illiteracy
- •Patient taking galantamine, memantine, rivastigmine within three months
- •Patient taking brain enhancer, thyroid hormone within 4 weeks
- •Patient taking Central nervous system stimulant, Antipsychotic agent, anticholinergic agent within 2 weeks
- •at screenig blood test: AST, ALT≥ 3 X upper limit of normal range or Hb≤8g/dL or platelet<100,000/mm3 or Serum creatinine ≥ 3 X upper limit of normal range
- •Abnormal result of Vit.B12, Syphilis serology, TSH
- •Severe Depression, Schizophrenia, Alcoholism, Drug addiction
- •Parkinson's disease (need to drug therapy)
- •Angina, Myocardial infarction, ischemia within six months
- •Head injury with sense of loss within six months
- •Patient taking other IP within three months
- •Hypersensitivity to IP
- •Sever Hearing problems or Visual impairment
研究组 & 干预措施
Active
Experimental
Acetyl-L-carnitine (DongA ST)
干预措施: Acetyl-L-Carnitine (Drug)
placebo
Placebo Comparator
Placebo of Acetyl-L-carnitine (DongA ST)
干预措施: Placebo of Acetyl-L-Carnitine (Drug)
结局指标
主要结局
ADAS-cog
时间窗: 24week
次要结局
- K-MMSE(12week, 24week)
研究者
研究点 (1)
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