SIM-2: Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05887674

Collaborator

Shanghai Sinopharm Nursing Care Center (Other)

180

Enrollment

Location

Arms

39.7

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Mild Dementia	Behavioral: Diet intervention Behavioral: Exercise Behavioral: Cognitive training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

May 11, 2023

Anticipated Primary Completion Date :

Aug 30, 2026

Anticipated Study Completion Date :

Aug 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multi-domain intervention group Patients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training.	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
Experimental: Exercise and cognitive training Patients in this arm will receive the intervention of exercise and cognitive training.	Behavioral: Exercise Guided muscle strength training and stretching exercises Behavioral: Cognitive training Cognitive training will be implemented in person
No Intervention: Standard health counseling at baseline Patients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided.

Arm

Intervention/Treatment

Experimental: Multi-domain intervention group

Patients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training.

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

Experimental: Exercise and cognitive training

Patients in this arm will receive the intervention of exercise and cognitive training.

Behavioral: Exercise

Guided muscle strength training and stretching exercises

Behavioral: Cognitive training

Cognitive training will be implemented in person

No Intervention: Standard health counseling at baseline

Patients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided.

Outcome Measures

Primary Outcome Measures

Change from baseline global cognitive function at one year [One year]
Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE)
Change from baseline memory at one year [One year]
Change from baseline verbal memory using the Auditory verbal learning test (AVLT)
Change from baseline visual spatial ability and visual memory at one year [One year]
Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)

Secondary Outcome Measures

Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test [One year]
Executive function
Changes in hippocampus related neural circuit-specific resting-state connectivity (FC) [One year]
Neural connectivity by functional MRI
Changes in structural brain MRI including volume of hippocampus and other specific brain regions [One year]
Brain structure by MRI
Changes in Inflammatory biomarkers [One year]
Serum interleukins and tumor necrosis factors
Changes in gut microbiota [One year]
Number of genera and abundance of microbiota in feces and blood
Changes in Metabolic biomarkers [One year]
Low-density lipoprotein, high-density lipoprotein, and total cholesterol

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)