Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment
SIMPLE
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedAugust 17, 2020
August 1, 2020
3.8 years
April 4, 2017
August 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of AD
The 3-year incidence of AD in each group will be compared.
12 months
Secondary Outcomes (9)
The global cognitive function of MCI patients
6 months
Memory
12 months
Attention
12 months
Executive functions
12 months
Language
12 months
- +4 more secondary outcomes
Study Arms (3)
online cognitive training
EXPERIMENTALPatients will receive 3-4 times of 20-30 minutes' training game every week
no training
NO INTERVENTIONPatients will not undergo preoperative cognitive training.
Cognitive training and physical exercise
EXPERIMENTALPatients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training
Interventions
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%.
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.
Eligibility Criteria
You may qualify if:
- Male or female, aged 50-85;
- MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups\[1\];
- ≤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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- RenJi Hospitalcollaborator
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Huashan Hospitalcollaborator
Study Sites (1)
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200002, China
Related Publications (1)
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.
PMID: 30041656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sheng-Di Chen
Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 18, 2017
Study Start
May 15, 2017
Primary Completion
March 1, 2021
Study Completion
May 1, 2021
Last Updated
August 17, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share