Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of AD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •The number of lacunar infarcts larger than 2 cm in diameter ≤
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of AD
时间窗: 12 months
The 3-year incidence of AD in each group will be compared.
次要结局
- Attention(12 months)
- Executive functions(12 months)
- Structural MRI(12 months)
- The global cognitive function of MCI patients(6 months)
- Activities of daily living(6 months)
- Memory(12 months)
- Language(12 months)
- Visual spatial ability and visual memory(12 months)
- Gut microbiota(12 months)
研究者
Binyin Li
Principle Investigator
Ruijin Hospital