Efficacy of Cognitive Training in Subjective Memory Impairment
2018年8月6日 更新者：Jae-Hong Lee、Asan Medical Center
A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment
This study evaluates the efficacy of cognitive training in subjects with subjective memory impairment.
The first group will receive cognitive training and lifestyle modification in combination, the second group will receive only lifestyle modification, and the third group will receive no intervention.
研究概览
详细说明
Subjective memory impairment is currently thought to be a risky state of progression to Alzheimer's disease.
This study aims to confirm whether cognitive training in subjective memory impairment would show improvement in the subjective and objective cognition.
We include subjects with normal cognition but complained subjective feeling of memory decline and conduct cognitive training programs combined with lifestyle modifications for 3 months.
We evaluate the neuropsychological tests and questionnaires about subjective improvement after 3 months of interventions.
研究类型
介入性
注册 (实际的)
65
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国
- Jae-Hong Lee
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects who showed normal range (above 16percentile of norm) in all domains of detailed neuropsychological tests battery named Seoul Neuropsychological Screening Battery (SNSB)
- Clinical dementia rating (CDR) score of 0
- Subjects with at least 3 years of formal education
Exclusion Criteria:
- Subjects with mild cognitive impairment or dementia
- Subjects who was diagnosed as any neurological disorders such as epilepsy, stroke, hemorrhage, hydrocephalus, Parkinson's disease or brain tumor
- Subjects with uncontrolled severe medical conditions according to investigator's opinion
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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：cognitive training
Cognitive training programs 2 times a week for 3 months (totally 24 sessions) for 90 minutes per session.
Lifestyle modification is educated first, then weekly phone call for lifestyle modification is done by investigators.
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cognitive training is held 2 times a week for 3 months, 90 minutes per 1 session.
It includes cognitive exercise of multiple cognitive domains such as memory, attention, calculation, executive function and visuospatial function.
education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications
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有源比较器：lifestyle modification
This group receives only lifestyle modification for 3 months.
Lifestyle modification is educated at the first, then weekly phone call for lifestyle modification is done by investigators.
The method of lifestyle modification is same with the first arm.
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education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications
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无干预：No intervention
This group receives no intervention.
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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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Paired associates learning test
大体时间：3 month
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paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery).
The scores are shown as total number of errors.
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3 month
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Rapid visual information processing test
大体时间：3 month
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rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB.
The score is shown as correct response rate.%
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3 month
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Pattern recognition memory test
大体时间：3 month
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paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery).
The score is shown as correct response rate.%
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3 month
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Spatial working memory test
大体时间：3 month
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paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery).
The scores are shown as total number of errors.
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3 month
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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 failure questionnaire
大体时间：3 month
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questionnaire for measuring self reported cognitive status.
score range: 0-100.
Higher score means worse cognitive status.
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3 month
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Mini-mental state examination
大体时间：3 month
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mini-mental state examination that examines general cognition.
range 0-20.
Higher score means better cognition.
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3 month
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Geriatric depression scale
大体时间：3 month
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questionnaire for depression measuring.
score range:0-15.
lower score means less depression.
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3 month
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Beck anxiety index
大体时间：3 month
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questionnaire for self reporting anxiety measuring.
range:0-63.
low score means less anxiety.
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3 month
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Seoul instrumental activities of daily living
大体时间：3 month
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scale for measuring activities of daily living limitation.
score range 0-45.
low score means better ability.
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3 month
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Rey complex figure copy test
大体时间：3 month
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test for visuospatial function.
Participants should copy the complex figure.
score range: 0-36.
Higher score means better visuospatial function.
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3 month
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Digit symbol test
大体时间：3 month
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a test for attention and psychomotor speed.
Participants are instructed to write an appropriately matched code for each number.
Correct number is counted.
score range: 0-76.
Higher score means better function.
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3 month
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Seoul verbal learning test, immediate recall
大体时间：3 month
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measuring tool for immediate memory function.
Investigators read 12 words to participants.
Participants should remember the words.
Tests are done 3 times.
score range: 0-36.
Higher score means better immediate memory function
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3 month
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Seoul verbal learning test, delayed recall
大体时间：3 month
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measuring tool for 20 minutes delayed memory function.
After 20 minutes from the immediate recall test, participants should remember the words.
score range: 0-12.
Higher score means better delayed memory function
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3 month
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Seoul verbal learning test, delayed recall
大体时间：3 month
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measuring tool for cued recall of verbal memory function.
score range: 0-24.
2. Higher score means better memory recognition function
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3 month
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Logical memory test, delayed recall
大体时间：3 month
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logical memory test is a part of a neuropsychological test named Wechsler
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3 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jae-Hong Lee, MD,PhD、Asan Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2016年2月1日
研究注册日期
首次提交
2015年9月18日
首先提交符合 QC 标准的
2015年9月21日
首次发布 (估计)
2015年9月22日
研究记录更新
最后更新发布 (实际的)
2018年8月7日
上次提交的符合 QC 标准的更新
2018年8月6日
最后验证
2018年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.