Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions in Healthy Adults With Subjective Cognitive Impairment: An 8-Week Prospective Randomized Double-Blind Placebo-Controlled Trial With Multimodal Neuroimaging and Neurocognitive Assessments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB)
研究概览
简要总结
The objective of this study is to demonstrate the cognitive enhancement effect and safety of Tremella Fuciformis, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 65 years old
- •Global Deterioration Scale score (GDS) of 2
- •High school or higher levels of education.
排除标准
- •Current pregnancy or breast-feeding
- •Evidence of neurologic or medical conditions
- •Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV)
- •Mini-mental status examination score of 24 or less
- •Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
- •Intelligence quotient less than 70
- •Contraindications to magnetic resonance imaging (MRI)
- •Use of psychotropics in last 3 months
- •Use of oral contraceptive medication
- •Participation in other clinical trials during the study period that might affect the outcome of the present study
- •Allergic adverse reactions to mushrooms
结局指标
主要结局
Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB)
时间窗: baseline, 8th week
Scores from neurocognitive test batteries such as CANTAB
Changes from baseline in brain function analyzed using the computational approach (Blood oxygenation level dependent (BOLD) signal intensity)
时间窗: baseline, 8 week
Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans
Changes from baseline in brain biochemical metabolism analyzed using the computational approach (Brain metabolite concentrations assessed using magnetic resonance spectroscopy)
时间窗: baseline, 8th week
Brain metabolite concentrations assessed using magnetic resonance spectroscopy
Changes from baseline in brain structure analyzed using the computational approach
时间窗: baseline, 8th week
Morphometric analysis of brain structures in magnetic resonance imaging
次要结局
- Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks(baseline, 8th week)
- Number of participants with adverse events(8th week)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University