An Open-label, Controlled, Cross-over Trial of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART) in Mild Cognitive Impairment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in the Word List Test (memory, recall, recognition) of the CERAD Neuropsychological Assessment Battery before and after phase I intervention and before and after phase II intervention (crossover part of the study)
研究概览
简要总结
The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI) by an open-label, controlled, crossover Trial.
详细描述
The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on the spaced retrieval training (SRT), which was effective in improving memory retention span of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by transforming the current SMART to a self-administered program using an application working on IPAD was developed, and showed its feasibility and efficacy in the elderly individuals with mild cognitive impairment in the preliminary study. (ClinicalTrials.gov ID: NCT01628653) To validate the efficacy of the U-SMART, an open-label, controlled, crossover design of clinical trial were planned in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 55-90
- •Educational level above 1 year and confirmed literacy
- •Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
- •Clinical Dementia Rating (CDR) of 0 or 0.5
排除标准
- •Diagnosed to dementia by DSM-IV
- •Evidence of delirium, confusion
- •Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
- •Evidence of severe cerebrovascular pathology
- •History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
- •History of substance abuse or dependence such as alcohol
- •Presence of depressive symptoms that could influence cognitive function
- •Presence of medical comorbidities that could result in cognitive decline Use of medication that could influence cognitive function seriously
结局指标
主要结局
Change in the Word List Test (memory, recall, recognition) of the CERAD Neuropsychological Assessment Battery before and after phase I intervention and before and after phase II intervention (crossover part of the study)
时间窗: Baseline, 5 weeks, 11weeks
To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT), Word List Recall Test (WLRT), Word List Recognition Test (WLRcT) of the CERAD neuropsychological assessment battery were applied to all participants.
次要结局
- Change in the Subjective Memory Complaints Questionnaire (SMCQ) before and after phase I intervention and before and after phase II intervention (crossover part of the study)(Baseline, 5 weeks, 11weeks)
- Change in the Geriatric Depression Scale (GDS) before and after phase I intervention and before and after phase II intervention (crossover part of the study)(Baseline, 5 weeks, 11weeks)
- Change in the Mini-Mental State Examination before and after phase I intervention and before and after phase II intervention (crossover part of the study)(Baseline, 5 weeks, 11weeks)
研究者
Ki Woong Kim
Professor, department of neuropsychiatry
Seoul National University Bundang Hospital