Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet intervention, Exercise, Cognitive training.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment, Mild Dementia. Basic parameters: 60 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Behavioral Diet intervention
Low inflammatory-index diet - Behavioral Exercise
Guided muscle strength training and stretching exercises - Behavioral Cognitive training
Cognitive training will be implemented in person
Primary outcome measures
- Change from baseline global cognitive function at one year [Time frame: One year]
- Change from baseline memory at one year [Time frame: One year]
- Change from baseline visual spatial ability and visual memory at one year [Time frame: One year]
Secondary outcome measures (6)
- Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test [Time frame: One year]
- Changes in hippocampus related neural circuit-specific resting-state connectivity (FC) [Time frame: One year]
- Changes in structural brain MRI including volume of hippocampus and other specific brain regions [Time frame: One year]
- Changes in Inflammatory biomarkers [Time frame: One year]
- Changes in gut microbiota [Time frame: One year]
- Changes in Metabolic biomarkers [Time frame: One year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT05887674 · RJNeuroBank-SIM2