ISRCTN50622732已完成不适用
An open-label, exploratory clinical trial to investigate the effects of Ginkgo biloba special extract EGb 761® on dopamine-induced executive cognitive functions and their neurophysiological correlation in subjects with mild cognitive deficits
Dr. W. Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 20 人开始时间: 2011年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 45 to 65 years
- •2. Informed consent according to legal requirements
- •3. Subject is capable to consent without any limitations
- •4. Existence of mild cognitive deficits, objectified by
- •4.1. A percentile below 16 in atleast 2 of 6 test parameters of the cognitive test battery
- •4.2. Alertness test (response time with/without audio warning)
- •4.3. Go/NoGo test (response time, mistakes)
- •4.4. Shared attention test (response time, mistakes) or
- •4.5 A percentile below 16 in one test parameter of the cognitive test battery and evidence of acquired attention disturbances and executive disturbances, relevant for every day life, i.e. questionnaire of experienced deficits of attention - distractibility and retardation in mental processes, FEDA-AV less than or equal to 45 or FEDA-EV less than or equal to 31 or fatigue and slowdown in practical activities, FEDA-AN less than or equal to 20
排除标准
- •1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment
- •2. Pregnancy or lactation period (exclusion by pregnancy test for all women of childbearing potential)
- •3. Women of child-bearing potential, i. e. who do not meet at least one of the following criteria:
- •3.1.Hormonal contraception for at least 6 months
- •3.2. Post menopausal status for at least 2 years
- •3.3. Hysterectomy
- •3.4. Bilateral oophorectomy
- •4. Active peptic ulcer disease or any gastrointestinal diseases with potential impairment of the absorption of orally applied drugs (e.g. Billroth I + II, Crohn´s disease, ulcerative colitis, any kind of enterectomy), celiac disease, dietically inadequately controlled lactose intolerance, other diseases causing malabsorption or chronical diarrhoea)
- •5. Persisting or recurrent neurological or psychiatric disorder at the time of enrolment
- •6. Severe, medically uncontrolled cardiovascular or pulmonary disease
- •7. Clinically relevant renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or Gamma GT above 3 times the upper limit of the reference range)
- •8. Other severe metabolic disorders or progressive diseases [e.g. insulin-dependent diabetes mellitus, anaemia, vitamin deficiencies, cancer, known human immunodeficiency virus (HIV) infection/Acquired immunodeficiency syndrome(AIDS), syphilis)
- •9. Abnormal neurological and/or psychopathological findings
- •10. Intake of prohibited medications
- •11. Total score in Mini-Mental-Status < 26
- •12. Status after apoplexia
- •13. Status after cranial or brain injury
- •14. Apraxia (i. e. Morbus Parkinson, Dystonia)
- •15. Severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the subject from co-operating adequately in the trial or that may interfere with neuropsychological test performance
- •16. Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under study
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