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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119051
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : August 17, 2020
Sponsor:
Collaborators:
RenJi Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Huashan Hospital
Information provided by (Responsible Party):
Binyin Li, Ruijin Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Behavioral: Online cognitive training Behavioral: Cognitive training plus physical exercise Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: online cognitive training
Patients will receive 3-4 times of 20-30 minutes' training game every week
Behavioral: 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%.

No Intervention: no training
Patients will not undergo preoperative cognitive training.
Experimental: 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
Behavioral: Cognitive training plus physical exercise

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.





Primary Outcome Measures :
  1. Incidence of AD [ Time Frame: 12 months ]
    The 3-year incidence of AD in each group will be compared.


Secondary Outcome Measures :
  1. The global cognitive function of MCI patients [ Time Frame: 6 months ]
    Alzheimer disease assessment scale (ADAS-Cog) will be used to assess the global cognitive performance of MCI patients

  2. Memory [ Time Frame: 12 months ]
    Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).

  3. Attention [ Time Frame: 12 months ]
    Attention will be evaluated by Trial Making Test (TMT).

  4. Executive functions [ Time Frame: 12 months ]
    Executive functions will be evaluated by the Stroop task.

  5. Language [ Time Frame: 12 months ]
    Language will be assessed by Boston naming test (30-item version).

  6. Visual spatial ability and visual memory [ Time Frame: 12 months ]
    Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).

  7. Activities of daily living [ Time Frame: 6 months ]
    Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).

  8. Structural MRI [ Time Frame: 12 months ]
    Volume of hippocampus and other specific brain regions

  9. Gut microbiota [ Time Frame: 12 months ]
    Number of genera and abundence of E.coli in feces and blood



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119051


Contacts
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Contact: Sheng-Di Chen 86-21-6445-4473 chen_sd@medmail.com.cn

Locations
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China, Shanghai
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200002
Contact: Binyin Li, Dr    86-13681884221    libinyin@126.com   
Contact: Yiqi Lin, Dr    86-021-64454473    linyiqi@126.com   
Sponsors and Collaborators
Ruijin Hospital
RenJi Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Huashan Hospital
Investigators
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Study Director: Sheng-Di Chen Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Binyin Li, Principle Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03119051    
Other Study ID Numbers: RuijinHSH
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Binyin Li, Ruijin Hospital:
mild cognitive impairment
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders