Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions in Healthy Adults With Subjective Memory 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
- 60
- 试验地点
- 1
- 主要终点
- Changes in standardized scores on a neuropsychological test battery
研究概览
简要总结
The objective of this study is to demonstrate the cognitive enhancement effect and safety of Fermented Codonopsis lanceolata, 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 65 years old
- •Global Deterioration Scale score (GDS) of 2
- •High school or higher levels of education
- •With informed consent
排除标准
- •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 25 or less
- •Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
- •Intelligence quotient less than 70
- •Any history of head trauma involving loss of consciousness or seizure
- •Contraindications to magnetic resonance imaging (MRI)
- •Use of psychotropics in last 3 months
- •Allergic adverse reactions to Fermented Codonopsis lanceolata
- •Participation in other clinical trials during the study period that might affect the outcome of the present study
- •Use of oral contraceptive medication
- •Current pregnancy or breast-feeding
研究组 & 干预措施
Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 525mg/day
干预措施: Fermented Codonopsis lanceolata 525mg (Dietary Supplement)
Fermented Codonopsis lanceolata 1050mg
Fermented Codonopsis lanceolata 1050mg/day
干预措施: Fermented Codonopsis lanceolata 1050mg (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in standardized scores on a neuropsychological test battery
时间窗: baseline, 4th week, 8th week
A composite z-scores were calculated from the scores of the neuropsychological test battery on attention and working memory. The test battery included Letter-number sequencing, Digit span (forward), and tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB) including the Match-to-Sample Visual Search, Reaction Rime, Rapid Visual Information Processing, and Stop Signal tasks.
次要结局
- Metabolic brain changes in magnetic resonance imaging assessed by computational approaches(baseline, 8th week)
- Changes in scores of the Subjective Memory Complaints Questionnaire(baseline, 4th week, 8th week)
- Number of participants with adverse events(4th week, 8th week)
- Changes of brain volume in magnetic resonance imaging assessed by computational approaches(baseline, 8th week)
- Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches(baseline, 8th week)
- Functional brain changes in magnetic resonance imaging assessed by computational approaches(baseline, 8th week)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University