Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease

Recruiting now · Not applicable

Conditions studied: Mild Cognitive Impairment, Mild Dementia

In brief

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.

Key facts

Study ID

NCT05887674

Run by

Ruijin Hospital

People needed

180

Starts

2023-05-11

Expected to finish

2026-08-30

Last updated by the study team

2024-11-22

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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 may not qualify 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)

Where it is running

• Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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