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

Primary Purpose

Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Online cognitive training
Cognitive training plus physical exercise
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring mild cognitive impairment

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

online cognitive training

no training

Cognitive training and physical exercise

Arm Description

Patients will receive 3-4 times of 20-30 minutes' training game every week

Patients will not undergo preoperative cognitive training.

Patients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training

Outcomes

Primary Outcome Measures

Incidence of AD
The 3-year incidence of AD in each group will be compared.

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2017
Last Updated
August 14, 2020
Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03119051
Brief Title
Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment
Acronym
SIMPLE
Official Title
Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
mild cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
online cognitive training
Arm Type
Experimental
Arm Description
Patients will receive 3-4 times of 20-30 minutes' training game every week
Arm Title
no training
Arm Type
No Intervention
Arm Description
Patients will not undergo preoperative cognitive training.
Arm Title
Cognitive training and physical exercise
Arm Type
Experimental
Arm Description
Patients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training
Intervention Type
Behavioral
Intervention Name(s)
Online cognitive training
Intervention Description
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%.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training plus physical exercise
Intervention Description
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 Measure Information:
Title
Incidence of AD
Description
The 3-year incidence of AD in each group will be compared.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The global cognitive function of MCI patients
Description
Alzheimer disease assessment scale (ADAS-Cog) will be used to assess the global cognitive performance of MCI patients
Time Frame
6 months
Title
Memory
Description
Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Time Frame
12 months
Title
Attention
Description
Attention will be evaluated by Trial Making Test (TMT).
Time Frame
12 months
Title
Executive functions
Description
Executive functions will be evaluated by the Stroop task.
Time Frame
12 months
Title
Language
Description
Language will be assessed by Boston naming test (30-item version).
Time Frame
12 months
Title
Visual spatial ability and visual memory
Description
Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).
Time Frame
12 months
Title
Activities of daily living
Description
Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
Time Frame
6 months
Title
Structural MRI
Description
Volume of hippocampus and other specific brain regions
Time Frame
12 months
Title
Gut microbiota
Description
Number of genera and abundence of E.coli in feces and blood
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Di Chen
Phone
86-21-6445-4473
Email
chen_sd@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Di Chen
Organizational Affiliation
Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binyin Li, Dr
Phone
86-13681884221
Email
libinyin@126.com
First Name & Middle Initial & Last Name & Degree
Yiqi Lin, Dr
Phone
86-021-64454473
Email
linyiqi@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30041656
Citation
Lin Y, Li B, Tang H, Xu Q, Wu Y, Cheng Q, Li C, Xiao S, Shen L, Tang W, Yu H, He N, Lin H, Yan F, Cao W, Yang S, Liu Y, Zhao W, Lu D, Jiao B, Xiao X, Zhou L, Chen S. Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology. BMC Neurol. 2018 Jul 24;18(1):103. doi: 10.1186/s12883-018-1100-x.
Results Reference
derived

Learn more about this trial

Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment

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