ACTRN12617001101370已完成4 期
Examining the Neurocognitive Effects of Bacopa monnieri Supplementation and Cognitive Training in Healthy Older Adults
Swinburne University of Technology, Centre for Human Psychopharmacology0 个研究点目标入组 28 人开始时间: 2017年7月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Male or female aged 55 years or above
- •2) Right handed
- •3) Has regular access to a computer with internet
- •4) Has corrected to normal vision
- •5) In good general health
- •6) Understands and is willing and able to comply with all study procedures
排除标准
- •1) Unable to understand or comply with testing procedures.
- •2) Evidence of clinical cognitive impairment as defined by a score of 23 or less in the Mini Mental State Examination (MMSE).
- •3) Evidence of clinical mood disturbance as defined by a score of 20 or more in the Beck Depression Inventory-II (BDI-II)
- •4) Is currently or within the last two years, has been diagnosed with a psychiatric disorder such as major depression, severe anxiety requiring treatment and/or schizophrenia.
- •5) Is currently diagnosed with a neurological disorder such as Alzheimer’s disease, Parkinson’s disease, stroke, epilepsy, brain tumours, or normal pressure hydrocephalus.
- •6) Has a history of repeated head injury.
- •7) Has experienced amnesia with or without loss of consciousness as a result of trauma to the head in the previous 14 days.
- •8) Has an active infection or sign/symptoms of an infection at V1.
- •9) Current diagnosis of a health condition which may affect food metabolism such as any inflammatory bowel diseases (e.g. , Crohn’s disease, ulcerative colitis), liver disease, allergies or kidney disease.
- •10) Has uncontrolled hypertension (systolic blood pressure more than140mmHg, diastolic blood pressure more than 90mmHg).
- •11) Currently taking supplements/ medication which has shown evidence to have cognitive altering effects and is unwilling to discontinue taking them four weeks prior and during the study period.
- •12) Female subjects currently pregnant or planning to conceive during the study period.
- •13) Currently participating in or has participated in another study involving an investigational product in the previous four weeks.
- •14) Has any implanted metal devices and electronically or magnetically activated devices.
- •15) Has claustrophobia.
- •16)Has had an MRI scan in the previous seven days before V1.
- •17) For blood test results only, significant hypotension before blood test at V1 (systolic blood pressure less than 90mmHg and diastolic blood pressure less than 60mmHg).
- •18) Currently taking illicit drugs or have a history of substance abuse
- •19) Currently consuming more than 14 standard alcoholic drinks per week.
- •20) Is a current smoker.
研究者
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