Mild Cognitive Impairment, Mild Dementia
Conditions
Keywords
mild cognitive impairment, Alzheimer's disease, Diet, Physical exercise, Cognitive training
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.
Detailed description
This 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. Patients who eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into three groups by a 1:1:1 ratio. Patients in first arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. Patients in the second arm will receive intervention of exercise and cognitive training. Patients in the third arm will receive regular health advice. We hypothesize that the multi-domain intervention will reduce impairment in the study group compared to the control group during the 2-year intervention period.
Interventions
BEHAVIORALDiet intervention
Low inflammatory-index diet
BEHAVIORALExercise
Guided muscle strength training and stretching exercises
BEHAVIORALCognitive training
Cognitive training will be implemented in person
Sponsors
Shanghai Sinopharm Nursing Care Center
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline global cognitive function at one year | One year | Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE) |
| Change from baseline memory at one year | One year | Change from baseline verbal memory using the Auditory verbal learning test (AVLT) |
| Change from baseline visual spatial ability and visual memory at one year | One year | Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Inflammatory biomarkers | One year | Serum interleukins and tumor necrosis factors |
| Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test | One year | Executive function |
| Changes in Metabolic biomarkers | One year | Low-density lipoprotein, high-density lipoprotein, and total cholesterol |
| Changes in gut microbiota | One year | Number of genera and abundance of microbiota in feces and blood |
| Changes in hippocampus related neural circuit-specific resting-state connectivity (FC) | One year | Neural connectivity by functional MRI |
| Changes in structural brain MRI including volume of hippocampus and other specific brain regions | One year | Brain structure by MRI |
Countries
China
Contacts
Primary ContactBinyin Li, Dr
Outcome results
None listed