Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function in Healthy Adults With Subjective Memory Complaints
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 Working Memory Domain Z-score
研究概览
简要总结
The objectives of the current study are to evaluate the efficacy and safety of HX106 in healthy adults with subjective memory complaints for improving cognitive and neurobiolgoical markers of memory.
详细描述
The objectives of the current study are to evaluate the efficacy and safety of HX106 in healthy adults with subjective memory complaints for improving neurocognitive functions and to find the changes of brain using magnetic resonance imaging and their associations with the neurocognitive function enhancement.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 60 years old,
- •Global Deterioration Scale score (GDS) of 2
- •One or more symptoms of subjective memory impairment
- •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),
- •One or more major depressive episode during last 12 months
- •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 80
- •Any history of head trauma involving loss of consciousness or seizure
- •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.
结局指标
主要结局
Changes From Baseline in Working Memory Domain Z-score
时间窗: Baseline, 8th week
To assess the working memory performance, four well-established tests, including the symbol span from the Wechsler Memory Scale-IV, immediate recall domain from the Rey-Osterrieth Complex Figure Test, digit span, and letter number sequencing from the Korean version of the Wechsler Adult Intelligence Scale were chosen. Each test score was adjusted with age, sex, intelligent quotient, years of education, and baseline test scores. The adjusted test scores were then standardized into z-scores using all participants' means and standard deviations. The relative improvement (positive z-scores) or decline (negative z-scores) in performance was measured in a unit-free manner using the obtained z-scores. The individual z-scores of each test were averaged to the composite score for working memory domain.
Changes From Baseline in White Matter Integrity Assessment
时间窗: Baseline, 8th weeks
次要结局
- Number of Participants With Adverse Events(8th weeks)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University