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NCT05887674 | RECRUITING | Mild Cognitive Impairment

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

Ruisin Hospital

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

Mild Cognitive Impairment

Mild Dementia

Intervention/treatment

Diet intervention

Exercise

Cognitive training

Phase

NA

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
Estimated Enrollment : 180 participants
Masking : SINGLE
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 : 2023-05-11
Estimated Primary Completion Date : 2026-08-30
Estimated Study Completion Date : 2026-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease

Location Details

NCT05887674

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Shanghai

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai, China, 200002