NCT02181972已完成3 期
Efficacy and Safety of Gingko Biloba Film-coated Tablets (2 x 60 mg Daily p.o.) in Improving Cognitive Functions and Neuropsychological Functioning of Middle-aged Cognitively Intact Adults: a Double-blind, Placebo-controlled, Parallel Group, Randomised Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention)
研究概览
简要总结
The primary objective of this study was to assess the efficacy and safety of Gingko biloba film-coated tablets in improving cognitive function and neuropsychological functioning of middle-aged cognitively intact adults.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy subjects with no known clinically significant pathology as assessed by the investigator
- •Mini-Mental State Examination (MMSE) score ≥ 28
- •Age range: 40 to 60, inclusive
- •Females must test negative for pregnancy
- •Clinical laboratory tests must be within normal limits or, if out of normal range, clinically acceptable to the Investigator
- •Urine drug screen for illicit drugs must be negative at screening
- •Subjects must have given written informed consent in accordance with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) and local laws and regulations
排除标准
- •Any serious disorder that may interfere with his/her participation in the trial and the evaluation of the safety of the test drug
- •Pre-treatment and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with the evaluation of cognitive function
- •Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistics Manual, Version IV)
- •Individuals drinking more than 6 cups of coffee or tea/day
- •Individuals smoking more than 10 cigarettes/day
- •Subjects who in the opinion of the investigator are heavy users of other tobacco or nicotine products
- •Subjects currently taking a cognition enhancing substance, including any Ginkgo or ginseng product
- •Any subject regularly taking a medication who might stop doing so at some time during the active dosing phase, if the medication is deemed by the investigator to influence the outcome of the trial
- •Female subjects of child-bearing age who are not using adequate means of birth control
- •Pregnancy and/or lactation
- •Any subject who, according to the Investigator, is unable to perform the CDR cognitive tests or the neuropsychological tests in a satisfactory and consistent manner
- •Relevant allergy or known hypersensitivity to the investigational product or its excipients
- •Individuals under anticoagulant treatment
- •Individuals with a current disorder likely to modify computerised cognitive testing
- •Individuals having a history of cancer (any type, excluding surgically removed and treated basal cell carcinoma)
- •Clinically significant and not treated thyroid disease
- •Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Gingko biloba
Experimental
干预措施: Gingko biloba (Drug)
结局指标
主要结局
Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention)
时间窗: pre-dose and 2, 4, 6 hours post-dosing at baseline and day 56
次要结局
- Changes from baseline in CDR factors(pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56)
- Changes from baseline in Stroop Colour and Word Test(Baseline and day 56)
- Changes from baseline in the Selective Reminding Test(Baseline and day 56)
- Changes from baseline in the Trail Making Test (Part A and B)(Baseline and day 56)
- Number of patients with adverse events(up to 56 days)
- Number of patients with clinically significant changes in vital signs(Baseline, days 28 and 56)
- Number of patients with abnormal changes in laboratory parameters(Baseline and day 56)
- Assessment of tolerability by subject on a 4-point scale(Days 28 and 58)
- Assessment of tolerability by investigator on a 4-point scale(Days 28 and 58)
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