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

Mild Cognitive Impairment Clinical Trial

— SIM-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887674
• Other study ID #: RJNeuroBank-SIM2
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: October 2022
• Source: Ruijin Hospital
• Contact: Binyin Li, Dr
• Phone: 021-64370045
• Email: lby11917[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mild Dementia

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Sinopharm Nursing Care Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline global cognitive function at one year	Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE)	One year
Primary	Change from baseline memory at one year	Change from baseline verbal memory using the Auditory verbal learning test (AVLT)	One year
Primary	Change from baseline visual spatial ability and visual memory at one year	Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)	One year
Secondary	Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test	Executive function	One year
Secondary	Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)	Neural connectivity by functional MRI	One year
Secondary	Changes in structural brain MRI including volume of hippocampus and other specific brain regions	Brain structure by MRI	One year
Secondary	Changes in Inflammatory biomarkers	Serum interleukins and tumor necrosis factors	One year
Secondary	Changes in gut microbiota	Number of genera and abundance of microbiota in feces and blood	One year
Secondary	Changes in Metabolic biomarkers	Low-density lipoprotein, high-density lipoprotein, and total cholesterol	One year