Lifestyle intervention for mild cognitive impairment and mild Alzheimer's disease
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
NA · Ruijin Hospital · NCT05887674
This study is testing if a combination of diet, exercise, and brain training can help people aged 60-90 with mild cognitive impairment and mild Alzheimer's disease think better over two years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05887674 on ClinicalTrials.gov |
What this trial studies
This multicentre, randomized, double-blind, controlled trial investigates the efficacy of a multi-domain lifestyle intervention that includes a low inflammatory-index diet, exercise, and cognitive training for patients with mild cognitive impairment and mild Alzheimer's disease. Eligible participants aged 60-90 will be randomly assigned to one of three groups: one receiving the full multi-domain intervention, another receiving only exercise and cognitive training, and a control group receiving regular health advice. The study aims to determine if the comprehensive intervention can reduce cognitive impairment over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60-90 diagnosed with mild cognitive impairment or mild Alzheimer's disease who meet specific inclusion criteria.
Not a fit: Patients with cognitive decline due to other neurological conditions or significant comorbidities may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could improve cognitive function and quality of life for patients with mild cognitive impairment and mild Alzheimer's disease.
How similar studies have performed: Previous studies have shown promising results with lifestyle interventions for cognitive impairment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Binyin Li, Dr
- Email: lby11917@rjh.com.cn
- Phone: 021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Cognitive Impairment, Mild Dementia, mild cognitive impairment, Alzheimer's disease, Diet, Physical exercise, Cognitive training