Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment

Not Applicable

• Conditions: Cognitive Dysfunction

• Registration Number: NCT03119051
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-05-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-17
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of AD	12 months	The 3-year incidence of AD in each group will be compared.

Secondary Outcome Measures

Name	Time	Method
Attention	12 months	Attention will be evaluated by Trial Making Test (TMT).
The global cognitive function of MCI patients	6 months	Alzheimer disease assessment scale (ADAS-Cog) will be used to assess the global cognitive performance of MCI patients
Activities of daily living	6 months	Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
Memory	12 months	Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Language	12 months	Language will be assessed by Boston naming test (30-item version).
Visual spatial ability and visual memory	12 months	Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).
Gut microbiota	12 months	Number of genera and abundence of E.coli in feces and blood
Executive functions	12 months	Executive functions will be evaluated by the Stroop task.
Structural MRI	12 months	Volume of hippocampus and other specific brain regions

Trial Locations

Locations (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China