Effects of Multimodal Cognitive Enhancement Therapy (MCET) for People With Mild Cognitive Impairment and Early Stage Dementia: a Randomized, Controlled, Double-blind, Cross-over Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in the Mini-Mental State Examination for dementia screening before and after period I and before and after period II intervention (crossover part of the study)
研究概览
简要总结
This study evaluates the effects of Multimodal Cognitive Enhancement Therapy (MCET) for people with mild cognitive impairment and early stage dementia by a randomized, controlled (mock-therapy), double-blind, cross-over trial
详细描述
Multimodal Cognitive Enhancement Therapy (MCET) was developed for cognitive rehabilitation of mild cognitive impairment or ealy dementia. MCET consists of cognitive training, cognitive stimulation, reality orientation, physical therapy, reminiscence therapy and music therapy that obtained 'A' grade of recommendation by SIGN(Scottish Intercollegiate Guidelines Network) for their efficacy (one of the followings: global cognition/specific cognitive domain/mood/activities of daily living/behavioral and psychological symptoms/quality of life) based on the systematic review and meta-analysis performed by our research team.
This study investigated the efficacy of MCET compared with mock-therapy that consisted of random activities that were not based on clinical evidences (e.g., watching TV, conversation etc.).
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosed to dementia by the Diagnostic and Statistical Manual, fourth edition (DSM-IV) or to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
- •Clinical Dementia Rating (CDR) of 0 or 0.5 for mild cognitive impairment, 0.5 or 1 for early dementia
排除标准
- •Evidence of current delirium, confusion
- •Any acute neurological conditions (infectious or inflammatory disorders such as viral, fungal or syphilis) or acute medical conditions
- •Current major psychiatric disorder by DSM-IV such as major depressive episode or manic or psychotic episode
结局指标
主要结局
Change in the Mini-Mental State Examination for dementia screening before and after period I and before and after period II intervention (crossover part of the study)
时间窗: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
To evaluate the effect on the global cognition
次要结局
- Change in the Disability Assessment for Dementia (DAD-K) before and after period I and before and after period II intervention (crossover part of the study)(baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2)
- Change in the Korean version of Alzheimer's Disease Assessment Scale -cognitive subscale of Korean version (ADAS-KCog) before and after period I and before and after period II intervention (crossover part of the study)(baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2)
- Change in the Quality of Life-AD (QoL-AD) of caregivers before and after period I and before and after period II intervention (crossover part of the study)(baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2)
- Change in the Quality of Life-AD (QoL-AD) of patients before and after period I and before and after period II intervention (crossover part of the study)(baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2)
- Change in the Revised Memory and Behavior Problems Checklist (RMBPC) before and after period I and before and after period II intervention (crossover part of the study)(baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2)
研究者
Ki Woong Kim
Professor
Seoul National University Bundang Hospital