Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
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
Ruijin Hospital
180 participants
May 11, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria10
- 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)
Interventions
Low inflammatory-index diet
Guided muscle strength training and stretching exercises
Cognitive training will be implemented in person
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05887674