NCT01046292已完成4 期
Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI: a Randomized, Double-blind, Placebo-controlled Exploratory Study
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- gait speed
研究概览
简要总结
The aim of this study is to evaluate the effects of Ginkgo Biloba Extract (GBE) in executive function-impaired Mild Cognitive Impairment (MCI) patients by assessing gait while walking alone as well as under differing dual-task conditions.
The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint is cycle time variability under dual-task conditions.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-85 years
- •Swiss German or German speaker
- •Completed elementary school
- •Impaired executive function (gait speed reduction ≥ 10% under dual-task as compared to normal walking)
- •No dementia according to International Classifications of Diseases (ICD)-10 and Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV.
- •Cognitive decline (self/informant report or objective task)
- •Preserved basic activities of daily living and minimal impairment in complex instrumental functions
- •Written informed consent and nihil obstat
排除标准
- •Current drug treatment with Warfarin-like drugs (Coumarins or Clopidogrel), however, acetylsalicylic acid 100mg and 300mg is permitted
- •Current intake of GBE or during the last 6 months
- •Known hypersensitivity to GBE or its constituents
- •Regular intake of antipsychotic, anxiolytic or sedative drugs(allowed if clinically stable for at least the past 3 months while under treatment)
- •Concomitant gait-relevant disorders: severe cardio/pulmonary/cerebron -vascular disorders, bleeding diathesis, polyneuropathy and severe orthopedic disorders, organic cerebral disease epilepsy, low vision
- •Severe medical conditions (e.g. chronic renal insufficiency, severe hepatic disorders,cardio-vascular disease, uncontrolled hypertension, peptic ulcer, malignoma)
- •Participation in another clinical intervention study within the last 2 months
- •Use of walking aid
- •Normal walking speed is < 100cm/s
研究组 & 干预措施
Ginkgo biloba
Experimental
干预措施: Ginkgo biloba (Drug)
Placebo control
Placebo Comparator
干预措施: Ginkgo biloba (Drug)
结局指标
主要结局
gait speed
时间窗: baseline, 3, 6, 12 months
次要结局
- cycle time variability(baseline, 3, 6, 12 months)
研究者
研究点 (1)
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