A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Composite working memory z score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Combined executive function and memory training (Device)
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.
结局指标
主要结局
Composite working memory z score
时间窗: Change from baseline composite working memory z score at week 26
composite score of digit span and spatial span
次要结局
- Mood(Change from baseline composite mood score at week 26)
- Brain structural imaging(change from baseline cortical thickness at week 26)
- Brain Functional Imaging(change from baseline functional connectivity at week 26)
- cognitive test package (CTP)(Changes from baseline composite CTP score at week 26)
- Electrical activity of the brain(change from baseline electrical brain activity at week 26)
- Self evaluated memory ability(Change from baseline self evaluated memory ability at week 26)
- cerebral blood flow(change from baseline cerebral blood flow at week 26)
- BDNF level(change from baseline serum BDNF level at week 26)
- Composite of overall cognition z scores(Changes from baseline composite overall cognition z score at week 26)
研究者
Huali Wang
Director of Clinical Research Division
Peking University