Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
Recruiting · NCT05887674 · Interventional (participants receive a specific treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive trainingDiet interventionExercise
What this trial is about
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.
Who can take part
Age range
60 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine - Shanghai, Shanghai Municipality, China