Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease: Combined Low Inflammatory-index Diet, Physical Exercises, and Cognitive Training in Nursing Home
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from baseline memory at one year
研究概览
简要总结
This study is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease.
详细描述
This is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease. Patients who eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into three groups by a 1:1:1 ratio. Patients in first arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. Patients in the second arm will receive intervention of exercise and cognitive training. Patients in the third arm will receive regular health advice. We hypothesize that the multi-domain intervention will reduce impairment in the study group compared to the control group during the 2-year intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60-90 years
- •In accordance with the diagnostic criteria for "mild cognitive impairment due to Alzheimer's disease" or "mild Alzheimer's disease" from the National Institutes of Health National Institute on Aging-Alzheimer's Association (NIA-AA) (2011)
- •The Hamilton depression rating scale/17 edition (HAMD) total score≤10
- •Neurological examination: no obvious signs
- •Education: primary school (grade 6) or above and capacity to complete tests for cognitive ability
- •Capacity to give consent
排除标准
- •Other causes of cognitive decline: cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's and Parkinson's disease, Creutzfeldt-Jakob disease, traumatic brain dementia, other physical and chemical factors (such as drugs, alcohol, CO), systemic disease (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupation (a subdural hematoma, brain tumor), the endocrine system disease (thyroid disease, parathyroid disease), and vitamins deficiency or any other causes of dementia
- •The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc
- •Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium
- •There are unstable or serious heart, lung, liver, kidney, endocrine, and hematopoietic system diseases, or Poor prognosis because of malignant diseases such as tumors.
- •Vision or hearing problems that lead to poor performance on cognitive tests
- •Two years history of severe alcoholism, and drug abuse
- •Participants who participated in any other trial 30 days prior to their screening visit
- •Contraindication of MRI scanning
- •Special requirements for diet, e.g., allergy to common food or on a special diet due to medical needs
- •Participants who cannot be followed for at least 6 months (due to a health situation or migration)
结局指标
主要结局
Change from baseline memory at one year
时间窗: One year
Change from baseline verbal memory using the Auditory verbal learning test (AVLT)
Change from baseline global cognitive function at one year
时间窗: One year
Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE)
Change from baseline visual spatial ability and visual memory at one year
时间窗: One year
Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)
次要结局
- Changes in Inflammatory biomarkers(One year)
- Changes in gut microbiota(One year)
- Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)(One year)
- Changes in structural brain MRI including volume of hippocampus and other specific brain regions(One year)
- Changes in Metabolic biomarkers(One year)
- Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test(One year)