KCT0006499已完成未知
Single center, randomized, double-blind, placebo-controlled clinical trial for evaluation of efficacy on cognitive function and safety of MT104
Kyung Hee University Hospital0 个研究点目标入组 86 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Subjects of 50 to 80 years of age
- •2) Subjects with mild cognitive impairment
- •- subjects or guardian claim cognitive impairment
- •- subjects with decreased verbal or visual memory score of SNSB test below -1SD
- •3) Subjects who consent participation of study and write written consent
排除标准
- •1) Subjects who experienced allergy or adverse events when administered functional food or drugs
- •2) Subjects who diagnosed with dementia, brain tumor, hydrocephalus
- •3) Subjects with gastrointestinal disturbance, or have psychiatric disorders (schizophrenia, epilepsy, alcohol intoxication, anorexia, abnormally increased appetite
- •4) Subjects with stroke, heart disease (heart failure, angina pectoris, myocardial infarction), malignancy, narrow angle glaucoma, uncontrolled hypertension (blood pressure over 60/100mmHg), or pulmanary diseases
- •5) Subjects with severe renal diseases or hepatic diseases (serum creatinine> 2.0 mg/dl, ALT, AST, alkaline phosphatase> normal upper limit x 2.5)
- •6) Subjects with uncontrolled blood glucose with hypoglycemic drugs (fasting blood glucose over160mg/dL), platelet (under 150,000/mm3) hemoglobin (male 9.5g/dL, female 9.0g/dL)
- •7) Subjects who treated with oral steroids, thyroid hormones or administered drugs or functional food which can change absorption, metabolism, and excretion of test food, or subjects who participated with other clinical trial within 3 month
- •8) Subjects who undergo surgery within 6 month or treated with prohibited treatment (acupuncture or treatment & functional food for brain function or drugs with abuse potential)
- •9) Subjects who undergo stomach resection or surgery which can influence drug absorption
- •10) pregnant woman, lactating woman, or fertile woman who do not consent proper contraception (oral contraceptive agent, hormone, uterine device, spermicide)
- •11) Subjects who donate blood with in 2 month or donate blood fraction within 1 month
- •12) Subjects who cannot participate in the study by investigator
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