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

Primary Purpose

Mild Cognitive Impairment, Mild Dementia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Diet intervention
Exercise
Cognitive training
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, Alzheimer's disease, Diet, Physical exercise, Cognitive training

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Multi-domain intervention group

Exercise and cognitive training

Standard health counseling at baseline

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)
Change from baseline memory at 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
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
Executive function
Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)
Neural connectivity by functional MRI
Changes in structural brain MRI including volume of hippocampus and other specific brain regions
Brain structure by MRI
Changes in Inflammatory biomarkers
Serum interleukins and tumor necrosis factors
Changes in gut microbiota
Number of genera and abundance of microbiota in feces and blood
Changes in Metabolic biomarkers
Low-density lipoprotein, high-density lipoprotein, and total cholesterol

Full Information

First Posted
May 15, 2023
Last Updated
June 2, 2023
Sponsor
Ruijin Hospital
Collaborators
Shanghai Sinopharm Nursing Care Center
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1. Study Identification

Unique Protocol Identification Number
NCT05887674
Brief Title
Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
Collaborators
Shanghai Sinopharm Nursing Care Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Mild Dementia
Keywords
mild cognitive impairment, Alzheimer's disease, Diet, Physical exercise, Cognitive training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-domain intervention group
Arm Type
Experimental
Arm Description
Patients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training.
Arm Title
Exercise and cognitive training
Arm Type
Experimental
Arm Description
Patients in this arm will receive the intervention of exercise and cognitive training.
Arm Title
Standard health counseling at baseline
Arm Type
No Intervention
Arm Description
Patients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided.
Intervention Type
Behavioral
Intervention Name(s)
Diet intervention
Intervention Description
Low inflammatory-index diet
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Guided muscle strength training and stretching exercises
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
Cognitive training will be implemented in person
Primary Outcome Measure Information:
Title
Change from baseline global cognitive function at one year
Description
Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE)
Time Frame
One year
Title
Change from baseline memory at one year
Description
Change from baseline verbal memory using the Auditory verbal learning test (AVLT)
Time Frame
One year
Title
Change from baseline visual spatial ability and visual memory at one year
Description
Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test
Description
Executive function
Time Frame
One year
Title
Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)
Description
Neural connectivity by functional MRI
Time Frame
One year
Title
Changes in structural brain MRI including volume of hippocampus and other specific brain regions
Description
Brain structure by MRI
Time Frame
One year
Title
Changes in Inflammatory biomarkers
Description
Serum interleukins and tumor necrosis factors
Time Frame
One year
Title
Changes in gut microbiota
Description
Number of genera and abundance of microbiota in feces and blood
Time Frame
One year
Title
Changes in Metabolic biomarkers
Description
Low-density lipoprotein, high-density lipoprotein, and total cholesterol
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binyin Li, Dr
Phone
021-64370045
Email
lby11917@rjh.com.cn
Facility Information:
Facility Name
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binyin Li, Dr
Phone
86-13681884221
Email
libinyin@126.com
First Name & Middle Initial & Last Name & Degree
Xiaomeng Xu, Dr
Phone
86-021-64454473
Email
xuxiaomeng@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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