Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
SIM-2
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2023
CompletedFirst Submitted
Initial submission to the registry
May 15, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
November 22, 2024
October 1, 2024
3.3 years
May 15, 2023
November 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Change from baseline memory at 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
Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)
One year
Secondary Outcomes (6)
Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test
One year
Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)
One year
Changes in structural brain MRI including volume of hippocampus and other specific brain regions
One year
Changes in Inflammatory biomarkers
One year
Changes in gut microbiota
One year
- +1 more secondary outcomes
Study Arms (3)
Multi-domain intervention group
EXPERIMENTALPatients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training.
Exercise and cognitive training
EXPERIMENTALPatients in this arm will receive the intervention of exercise and cognitive training.
Standard health counseling at baseline
NO INTERVENTIONPatients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided.
Interventions
Guided muscle strength training and stretching exercises
Cognitive training will be implemented in person
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Shanghai Sinopharm Nursing Care Centercollaborator
Study Sites (1)
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2023
First Posted
June 5, 2023
Study Start
May 11, 2023
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
November 22, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share