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

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.

Study Overview

• Status: Unknown
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Online cognitive training; Behavioral: Cognitive training plus physical exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200002
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: Binyin Li, Dr; Phone Number: 86-13681884221; Email: libinyin@126.com
      • Contact: Yiqi Lin, Dr; Phone Number: 86-021-64454473; Email: linyiqi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AD	The 3-year incidence of AD in each group will be compared.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Memory	Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).	12 months
Attention	Attention will be evaluated by Trial Making Test (TMT).	12 months
Executive functions	Executive functions will be evaluated by the Stroop task.	12 months
Language	Language will be assessed by Boston naming test (30-item version).	12 months
Visual spatial ability and visual memory	Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).	12 months
Activities of daily living	Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).	6 months
Structural MRI	Volume of hippocampus and other specific brain regions	12 months
Gut microbiota	Number of genera and abundence of E.coli in feces and blood	12 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital; Huashan Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Sheng-Di Chen, Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: mild cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: RuijinHSH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No