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Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment (SIMPLE)

2020年8月14日 更新者:Binyin Li、Ruijin Hospital

Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation

This study evaluates the effects of "computerized cognitive training" and "cognitive training plus exercise training" on different cognitive domains in mild cognitive impairment (MCI) patients. Patients will be randomized into the computerized training group, cognitive training plus exercise training group and the control group.

研究概览

详细说明

Mild cognitive impairment (MCI) is an early stage of Alzheimer Disease (AD). Increasing evidence has indicated that cognitive trainings improve cognition functions of MCI patients in multiple cognitive domains, making it a promising therapy for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent of its function in reducing the conversion rate from MCI to AD.

研究类型

介入性

注册 (预期的)

250

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

    • Shanghai
      • Shanghai、Shanghai、中国、200002
        • 招聘中
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • 接触:
        • 接触:

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or female, aged 50-85;
  • MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups[1];
  • 24≤Mini-Mental State Examination (MMSE) ≤28;
  • The Hamilton Depression Scale/17-item (HAMD) score ≤10;
  • Not on medication for dementia;
  • MRI T2 weighted image (T2WI) scan: aged ≤70 , Fazeca scale for White Matter lesions rating level≤1; >70 years, white matter damage rating scale ≤2. The number of lacunar infarcts larger than 2 cm in diameter ≤2. No infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. The medial temporal lobe atrophy (MTA) score: Grade II or above.
  • Accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like ADCS-ADL;
  • Education level: primary school (grade 6) or above.
  • Expected good compliance with the therapy and follow-up. Each patient gives a written informed consent, and the study has been approved by Ruijin Hospital's ethical committees.

Exclusion Criteria:

  • Cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, Parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin B12 and hypothyroidism);
  • Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);
  • Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;
  • Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;
  • History of alcohol or drug abuse;
  • Participation in other clinical trial less than 30 days before the screening of this study;
  • Inability to complete the study.

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
实验性的:online cognitive training
Patients will receive 3-4 times of 20-30 minutes' training game every week
A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
无干预:no training
Patients will not undergo preoperative cognitive training.
实验性的:Cognitive training and physical exercise
Patients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training

Online cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.

Physical Exercise Tai Chi Training:a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction.

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
Incidence of AD
大体时间:12 months
The 3-year incidence of AD in each group will be compared.
12 months

次要结果测量

结果测量
措施说明
大体时间
The global cognitive function of MCI patients
大体时间:6 months
Alzheimer disease assessment scale (ADAS-Cog) will be used to assess the global cognitive performance of MCI patients
6 months
Memory
大体时间:12 months
Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
12 months
Attention
大体时间:12 months
Attention will be evaluated by Trial Making Test (TMT).
12 months
Executive functions
大体时间:12 months
Executive functions will be evaluated by the Stroop task.
12 months
Language
大体时间:12 months
Language will be assessed by Boston naming test (30-item version).
12 months
Visual spatial ability and visual memory
大体时间:12 months
Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).
12 months
Activities of daily living
大体时间:6 months
Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
6 months
Structural MRI
大体时间:12 months
Volume of hippocampus and other specific brain regions
12 months
Gut microbiota
大体时间:12 months
Number of genera and abundence of E.coli in feces and blood
12 months

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

  • 研究主任:Sheng-Di Chen、Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2017年5月15日

初级完成 (预期的)

2021年3月1日

研究完成 (预期的)

2021年5月1日

研究注册日期

首次提交

2017年4月4日

首先提交符合 QC 标准的

2017年4月13日

首次发布 (实际的)

2017年4月18日

研究记录更新

最后更新发布 (实际的)

2020年8月17日

上次提交的符合 QC 标准的更新

2020年8月14日

最后验证

2020年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • RuijinHSH

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

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Online cognitive training的临床试验

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