Computerized Cognitive Training for MCI
A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
研究概览
详细说明
Introduction:
Mild cognitive impairment (MCI) is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia, but are more pronounced than the cognitive decline associated with normal aging. The prevalence of MCI ranges from 3% to 19% in adults older than 65 years; some of these individuals seem to remain stable or return to normal over time, but more than half progress to dementia within 5 years. Thus, MCI represents a critical window of opportunity for intervening and altering the trajectory of both cognitive decline and loss of functional independence in older adults. Cognitive function apart from memory such as executive function is also impaired in patients with MCI. However, no study has yet placed sufficient emphasis on the training of executive function.
Objectives:
The objective of the study is to evaluate whether memory training combined with executive training could lead to improved cognitive and noncognitive performance in patients with MCI. Furthermore, we will explore the neural correlates underlying the changed performances.
Patients and Methods:
The proposed study is a single blinded, randomized and controlled trial that will include 120 elderly patients with MCI from the memory clinic. The groups will be randomized to either intervention or waiting-list group. The intervention is computerized combined memory and executive function training performed for 60 minutes x 4 times/week over 26 weeks. A neuropsychological assessment will be administered at baseline and week 4, 12 and 26 after the intervention. The structural and functional MRI, EEG and NIRS will be performed at baseline and week 26 after intervention for a sub-study on the effect of cognitive training on brain structure and function.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100191
- 招聘中
- Peking University Institute of Mental Health(Six Hospital)
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接触：
- Haifeng Zhang, MS
- 电话号码：86+18813185360
- 邮箱：zhfphd@gmail.com
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接触：
- Xiaozhen Lv, PhD
- 电话号码：86+82801983
- 邮箱：lxz120300@163.com
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首席研究员：
- Huali Wang, MD
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副研究员：
- Haifeng Zhang, MS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- An objective cognition impairment (a Montreal Cognitive Assessment (MoCA) score < 26)
- Preserved general cognitive function( an mini-mental state examination (MMSE) score of > 24)
- Clinical Dementia Rating (CDR) = 0.5
- Hamilton Depression Scale (HAMD) score of < 12
- Intact activities of daily living (ADL score of <=26)
- Schooling education > = 5 years)
- Not meeting the diagnosis of dementia (according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Probable Alzheimer's Criteria
Exclusion Criteria:
- Serious visual or hearing impairment;
- Hachinski Ischemia Scale (HIS) >= 4;
- Subjects with Axis I disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), any other neurological disorders that could affect cognitive function;
- currently on titration of medications with cognitive enhancers or antidepressants;
- having any physical condition that could preclude regular attendance and full intervention-program participation
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Combined cognitive training
The training is combined executive function and memory training.
The training is considered 'adaptive', which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times.
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Computerized combined executive function and memory training
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无干预：Waiting-list group
Participants in the control condition will conduct the same training as the intervention group after a 26-week waiting period.
During the 26-week waiting period, the participants will receive assessment with the same protocol as the interventional group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Composite working memory z score
大体时间：Change from baseline composite working memory z score at week 26
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composite score of digit span and spatial span
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Change from baseline composite working memory z score at week 26
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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cognitive test package (CTP)
大体时间：Changes from baseline composite CTP score at week 26
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composite score of episodic memory, speed processing, executive function, attention, language and social cognition
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Changes from baseline composite CTP score at week 26
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Self evaluated memory ability
大体时间：Change from baseline self evaluated memory ability at week 26
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Score on the questionnaire probes worries about memory (MMQ-contentment).
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Change from baseline self evaluated memory ability at week 26
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Brain Functional Imaging
大体时间：change from baseline functional connectivity at week 26
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Brain function measured with MRI.
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change from baseline functional connectivity at week 26
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Electrical activity of the brain
大体时间：change from baseline electrical brain activity at week 26
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Brain activity measured with electroencephalography (EEG).
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change from baseline electrical brain activity at week 26
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Brain structural imaging
大体时间：change from baseline cortical thickness at week 26
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cortical thickness measured with MRI
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change from baseline cortical thickness at week 26
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cerebral blood flow
大体时间：change from baseline cerebral blood flow at week 26
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Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).
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change from baseline cerebral blood flow at week 26
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Mood
大体时间：Change from baseline composite mood score at week 26
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composite score of mood status
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Change from baseline composite mood score at week 26
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BDNF level
大体时间：change from baseline serum BDNF level at week 26
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Serum Brain-derived neurotrophic factor (BDNF) level
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change from baseline serum BDNF level at week 26
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Composite of overall cognition z scores
大体时间：Changes from baseline composite overall cognition z score at week 26
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Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).
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Changes from baseline composite overall cognition z score at week 26
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合作者和调查者
调查人员
- 首席研究员：Huali Wang, MD、Peking University Institute of Mental Health(Sixth hospital)
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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