Clinical trial NCT05887674: Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Keywords: mild cognitive impairment
Alzheimer's disease
Diet
Physical exercise
Cognitive training
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Sinopharm Nursing Care Center
First posted: 2023-06-05
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Change from baseline global cognitive function at one year
timeFrame: One year
measure: Change from baseline memory at one year
timeFrame: One year
measure: Change from baseline visual spatial ability and visual memory at one year
timeFrame: One year
Secondary outcomes:
measure: Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test
timeFrame: One year
measure: Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)
timeFrame: One year
measure: Changes in structural brain MRI including volume of hippocampus and other specific brain regions
timeFrame: One year
measure: Changes in Inflammatory biomarkers
timeFrame: One year
measure: Changes in gut microbiota
timeFrame: One year
measure: Changes in Metabolic biomarkers
timeFrame: One year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: