Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
NCT ID: NCT05887674
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-05-11
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Multi-domain intervention group
Patients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training.
Diet intervention
Low inflammatory-index diet
Exercise
Guided muscle strength training and stretching exercises
Cognitive training
Cognitive training will be implemented in person
Exercise and cognitive training
Patients in this arm will receive the intervention of exercise and cognitive training.
Exercise
Guided muscle strength training and stretching exercises
Cognitive training
Cognitive training will be implemented in person
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.
No interventions assigned to this group
Interventions
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Diet intervention
Low inflammatory-index diet
Exercise
Guided muscle strength training and stretching exercises
Cognitive training
Cognitive training will be implemented in person
Eligibility Criteria
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Inclusion Criteria
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 scoreā¤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
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)
60 Years
90 Years
ALL
No
Sponsors
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Shanghai Sinopharm Nursing Care Center
UNKNOWN
Ruijin Hospital
OTHER
Responsible Party
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Locations
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Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RJNeuroBank-SIM2
Identifier Type: -
Identifier Source: org_study_id
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