The purpose of this study is to evaluate the efficacy of electroacupuncture in the treatment of agitation symptoms in patients with Alzheimer's disease (AD). Meanwhile the study aims to explore the brain central mechanism of electroacupuncture in the treatment of agitation symptoms in patients with AD by using resting state functional magnetic resonance technology.
Meet the revised draft diagnostic criteria for Alzheimer's disease published by the Alzheimer's Association in 2023
Meet the 2023 IPA definition of agitated symptoms of cognitive impairment
Cohen Mansfield Agitation Inventory (CMAI)≥45 points
Have been on stable anti-AD medication (cholinesterase inhibitors, etc.) for more than 1 month
There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
Received electroacupuncture treatment in the past 2 weeks
At the time of the screening, participants are participating in other clinical trials or planned to participate in other clinical trials in the next 17 weeks.
Parallel
Electroacupuncture group
Other interventionElectroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes.
Micro-acupuncture group
Other interventionAfter acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds.
Cohen Mansfield Agitation Inventory (CMAI)
CMAI is one of the most widely used tools for assessing agitated behaviors that affect patients' quality of life and burden caregivers. The scale contains 29 items, including different agitated behaviors and emotional states, to which the assessed responds based on their own observations and experiences. The scores for all items are added together to give a total score. The higher the score, the more severe the agitated behavior.
Cohen Mansfield Agitation Inventory (CMAI)
CMAI is one of the most widely used tools for assessing agitated behaviors that affect patients' quality of life and burden caregivers. The scale contains 29 items, including different agitated behaviors and emotional states, to which the assessed responds based on their own observations and experiences. The scores for all items are added together to give a total score. The higher the score, the more severe the agitated behavior.
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change(mADCS-CGIC)
mADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient agitation on the mADCS-CGIC as: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7) compared to baseline symptoms.
the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)
The BEHAVE-AD scale is used to assess the behavioral pathology of patients with Alzheimer's disease. It contains 25 items to assess patients' symptoms and severity across multiple behavioral areas. The higher the total score of BEHAVE-AD, the more serious the behavioral pathology of the patient.
Neuropsychiatric Inventory (NPI)
NPI is used to evaluate neuropsychiatric behavioral symptoms of dementia patients. The scale assesses the neuropsychiatric disorders of patients according to the caregiver's view of the patient's behavior and the corresponding distress felt by the patient. The scoring range of the patient evaluation scale is 0-144 points, and the scoring of the caregiver distress scale is 0-60 points, the lower the score is, the better the patient's condition is.
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