Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment
- Conditions
- Cognitive Dysfunction
- Interventions
- Behavioral: Online cognitive trainingBehavioral: Cognitive training plus physical exercise
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- 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.
- 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
- Arm && Interventions
Group Intervention Description online cognitive training Online cognitive training Patients will receive 3-4 times of 20-30 minutes' training game every week Cognitive training and physical exercise Cognitive training plus 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
- 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).
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
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
Trial Locations
- Locations (1)
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China