Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease (NCT05887674) | Clinical Trial Compass
RecruitingNot Applicable
Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
China180 participantsStarted 2023-05-11
Plain-language 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.
Who can participate
Age range60 Years – 90 Years
SexALL
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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.
What they're measuring
1
Change from baseline global cognitive function at one year
Timeframe: One year
2
Change from baseline memory at one year
Timeframe: One year
3
Change from baseline visual spatial ability and visual memory at one year