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

November 21, 2024 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200002
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Shanghai Sinopharm Nursing Care Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJNeuroBank-SIM2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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