A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of CUQ-1720Q on management of cognitive functions in Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change in Neuro cognitive battery
研究概览
简要总结
This is a randomized (1:1), double-blind, placebo-controlled, parallel group clinical study. Healthy subjects with normal cognition assessed by Mini-Mental State Examination (MMSE)and meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms in 50:50 ratio to receive CurQfen® 500 mg or placebo, orally twice a day for a period of 12 weeks (84 days).The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments including biomarker analysis. Post blood sample collection, the subjects will undergo assessments to evaluate their cognitive functions The subjects will visit the study site 3 times during the 12-week study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with normal cognitive function 2.Subjects with a MMSE Score ≥ 23 3.Diabetes, hypertension and other medical condition patients should be on stable medication for last 3 months.
- •4.Should not be an any medication for cognition and other neurological disorders.
- •5.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 6.Non-smokers 7.Able to communicate verbally, able to write and speak English and comfortable with using computer 8.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Subject with chronic diseases.
- •2.Subjects who maybe allergic to any of the natural constituents of the Investigational Product.
- •3.Known HIV or Hepatitis B positive or any other immuno-compromised state 4.Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime.
- •5.Subjects visually or mentally handicapped or having difficulty to communicate 6.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •7.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
结局指标
主要结局
change in Neuro cognitive battery
时间窗: Day 0, Day 42, Day 84
次要结局
- Over all Sfety(Day 0, Day 42, Day 84)
- Changes in Biomarkers(Day 0, Day 84)