ACTRN12614001024639已完成2 期
A randomised controlled study, investigating the epigenetic changes in expression of inflammatory genes through associated blood biomarkers, using curcumin, in older healthy and mild cognitive impairment participants
McCusker Alzheimers Research Foundation0 个研究点目标入组 48 人开始时间: 2014年9月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 65 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Arm 1: Healthy Volunteers
- •1. Age 65-90 years, with general good health.
- •2. No significant history of cerebral vascular disease, such as
- •a stroke, within the last 5 years.
- •3. Living in independent living units, or similar accommodation
- •4. English speaker, with adequate vision and hearing to enable testing
- •5. Normal general cognitive function, as determined by a Montreal Cognitive Assessment (MoCA) score, greater than or equal to 26.
- •6. No change in ADLs as determined by a clinical interview, and confirmed by an informant using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
- •Arm 2: Mild Cognitive Impairment Volunteers
- •1-4, as listed above
- •5. Impairment in one or more cognitive domains including memory, executive function, attention, language, and visuospatial skills
- •6.A MoCa score of between 25-18 (age and education stratified) as agreed based on a clinical panel review.
- •7.Preservation of independence in functional abilities.
排除标准
- •1. Diagnosis of dementia based on the revised NIA/AA criteria
- •2. MoCA score of less than or equal to 17
- •3. Prior history of stroke within the last 5 years
- •4. Significant psychiatric disorder, including schizophrenia or
- •bipolar disorder
- •5. History of alcohol or drug abuse / dependence within 2
- •years of screening
- •6. Uncontrolled, clinical or subclinical depression as evidenced
- •by a score of greater or equal to 4 on the Geriatric
- •Depression scale.
- •7. Uncontrolled hypertension (systolic BP >170; diastolic BP >
- •8. Gastro-intestinal symptoms or conditions that are
- •considered contra-indicated in the use of curcumin e.g.
- •obstruction of the biliary tract
研究者
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