Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Diet intervention
  Low inflammatory-index diet
• Поведенческое Exercise
  Guided muscle strength training and stretching exercises
• Поведенческое Cognitive training
  Cognitive training will be implemented in person

Первичные конечные точки

• Change from baseline global cognitive function at one year [Срок оценки: One year]
• Change from baseline memory at one year [Срок оценки: One year]
• Change from baseline visual spatial ability and visual memory at one year [Срок оценки: One year]

Вторичные конечные точки (6)

• Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test [Срок оценки: One year]
• Changes in hippocampus related neural circuit-specific resting-state connectivity (FC) [Срок оценки: One year]
• Changes in structural brain MRI including volume of hippocampus and other specific brain regions [Срок оценки: One year]
• Changes in Inflammatory biomarkers [Срок оценки: One year]
• Changes in gut microbiota [Срок оценки: One year]
• Changes in Metabolic biomarkers [Срок оценки: One year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT05887674 · RJNeuroBank-SIM2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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