Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment (CogMCI)
2013年8月27日 更新者：Chul Soo Kim、Inha University Hospital
A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment
- There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group.
- There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.
研究概览
详细说明
The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.
研究类型
介入性
注册 (实际的)
293
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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Ansan、大韩民国
- Korea University Medical College
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Bucheon、大韩民国、420-767
- Soonchunhyang University Hospital
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Bucheon、大韩民国
- Bucheon St. Mary's Hospital, The Catholic University of Korea
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Busan、大韩民国
- Pusan National University Hospital
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Busan、大韩民国、602-715
- DongA University Hospital
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Daejun、大韩民国、302-799
- Daejun Eulji University Hopistal
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Goyang、大韩民国
- NHIC Ilsan Hospital
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Goyang、大韩民国、412-270
- MyongJi Hospital
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Incheon、大韩民国、400-711
- Inha Univeristy Hospital
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Jeju、大韩民国
- Jeju National University Hospital
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Pusan、大韩民国
- Maryknoll Hospital
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Seongnam、大韩民国
- bobath Memorial Hospital
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Seoul、大韩民国
- Inje University Sanggye Paik Hospital
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Seoul、大韩民国、135-710
- Sungkyunkwan University, Samsung Seoul Hospital
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Seoul、大韩民国、431-060
- Asan Medical Center, Psychiatry
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Seoul、大韩民国
- Konkuk University Medical Cener
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Suwon、大韩民国
- Ajou University Hospital
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Yongin、大韩民国
- Hyoja Geriatric Hospital
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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
50年 至 85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:
- 50 to 85 years of age
- memory complaint corroborated by a participant and an informant
- delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
- Global CDR score is 0.5, Memory CDR score is 0.5 or 1.
- above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
- normal functional activities
- not diagnosed with dementia
- Modified Hachinski Ischemic Score (HIS): 0-4
- brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
- Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
- He/She can read and write
- written informed consent
Exclusion Criteria:
- any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
- any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
- any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
- any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
- any patients with any history of drug or alcohol addiction during the past 10 years
- any hearing or visual impairment that can disturb the efficient evaluation of the patient
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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有源比较器：Group cognitive intervention
The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics.
Each session will last approximately 90 minutes.
The cognitive training programs will be offered in group sessions consisted of 5 participants.
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The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics.
Each session will last approximately 90 minutes.
The cognitive training programs will be offered in group sessions consisted of 5 participants.
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有源比较器：Home-based cognitive intervention
The participants will do their homework for 30 minutes every business days for 12 weeks.
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The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
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无干预：Wait list Control
They will participate in cognitive intervention after ending this study.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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story recall test
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Digit span forward and backward
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Word fluency test
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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color-word stroop test
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Digit symbol test
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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prospective memory test
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Mini-Mental State Examination
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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CDR-SB
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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K-AD8
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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PRMQ
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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MMQ-Strategy
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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QOL-AD
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Geriatric Depression Scale-short form
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Bayer ADL
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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CGA-NPI
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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Subjective cognitive assessment
大体时间：postintervention, 12 weeks follow-up, and 24 weeks follow-up
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postintervention, 12 weeks follow-up, and 24 weeks follow-up
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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。
合作者
调查人员
- 首席研究员：Seong H Choi, MD, PhD、Inha University Hospital
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
2011年3月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2013年1月1日
研究注册日期
首次提交
2011年5月20日
首先提交符合 QC 标准的
2011年5月20日
首次发布 (估计)
2011年5月24日
研究记录更新
最后更新发布 (估计)
2013年8月28日
上次提交的符合 QC 标准的更新
2013年8月27日
最后验证
2013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.