NCT05887674 · RECRUITING
Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
This trial is testing whether a combination of three lifestyle changes — an anti-inflammatory diet, regular exercise, and cognitive training — can slow mental decline in people who already have mild cognitive impairment or early Alzheimer's disease. It is a Phase NA, meaning it is a controlled behavioral trial rather than a drug study. Researchers want to know if doing all three together makes a meaningful difference over time.
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're excluded 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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-11-22