Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment

Cognitive Dysfunction Clinical Trial

— SIMPLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03119051
• Other study ID #: RuijinHSH
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: May 2021

Study information

• Verified date: August 2020
• Source: Ruijin Hospital
• Contact: Sheng-Di Chen
• Phone: 86-21-6445-4473
• Email: chen_sd[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

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%.
• 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.

Locations

Country	Name	City	State
China	Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Huashan Hospital, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AD	The 3-year incidence of AD in each group will be compared.	12 months
Secondary	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
Secondary	Memory	Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).	12 months
Secondary	Attention	Attention will be evaluated by Trial Making Test (TMT).	12 months
Secondary	Executive functions	Executive functions will be evaluated by the Stroop task.	12 months
Secondary	Language	Language will be assessed by Boston naming test (30-item version).	12 months
Secondary	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
Secondary	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
Secondary	Structural MRI	Volume of hippocampus and other specific brain regions	12 months
Secondary	Gut microbiota	Number of genera and abundence of E.coli in feces and blood	12 months