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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Mild Dementia; Mild Cognitive Impairment

Treatments: Behavioral: Exercise; Behavioral: Cognitive training; Behavioral: Diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05887674

RJNeuroBank-SIM2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 60-90 years
2. 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)
3. The Hamilton depression rating scale/17 edition (HAMD) total score≤10
4. Neurological examination: no obvious signs
5. Education: primary school (grade 6) or above and capacity to complete tests for cognitive ability
6. Capacity to give consent

Exclusion criteria

1. 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
2. The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc
3. Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium
4. There are unstable or serious heart, lung, liver, kidney, endocrine, and hematopoietic system diseases, or Poor prognosis because of malignant diseases such as tumors.
5. Vision or hearing problems that lead to poor performance on cognitive tests
6. Two years history of severe alcoholism, and drug abuse
7. Participants who participated in any other trial 30 days prior to their screening visit
8. Contraindication of MRI scanning
9. Special requirements for diet, e.g., allergy to common food or on a special diet due to medical needs
10. Participants who cannot be followed for at least 6 months (due to a health situation or migration)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Multi-domain intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Diet intervention

Behavioral: Cognitive training

Behavioral: Exercise

Exercise and cognitive training

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive training

Behavioral: Exercise

Standard health counseling at baseline

No Intervention group

Description:

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