Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease
NCT Number: NCT06495957
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Agitation Associated With Alzheimer's Dementia|Alzheimer's Dementia
Interventions: OTHER: Electroacupuncture group|OTHER: Micro-acupuncture group
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2027-10-31
Locations: Beijing United Family Rehabilitation Hospital, Beijing, Beijing, 100015, China|China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing, 100053, China|Xuanwu Hospital of Capital Medical University, Beijing, Beijing, 100053, China|Beijing Geriatric Hospital, Beijing, Beijing, 100095, China|Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, 350122, China|The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Ha'erbin, Heilongjiang, 150001, China

Summary:
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.

Primary Outcome Measures: 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., CMAI will be evaluated after the final treatment at week 8
Secondary Outcome Measures: 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., The CMAI will be evaluated at week 4 of treatment and at week 4 and week 8 of follow-up|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 mADCS-CGIC assessment will be completed before treatment and at week 8 of treatment.|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., The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.|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., NPI will be completed before treatment and at week 8 of treatment.|Mini-mental State Examination (MMSE), The MMSE scale can comprehensively, accurately and quickly reflect the intellectual state and cognitive function defect of the subjects. The total score ranges from 0 to 30 points, and the higher the score is, the better the cognitive function is, MMSE will be completed before treatment and at week 8 of treatment.|Alzheimer disease assessment scale cognition (ADAS-Cog), The ADAS-Cog scale is a scale commonly used to assess cognitive impairment in Alzheimer's patients on a scale ranging from 0 to 70 points, with higher scores indicating more severe cognitive impairment., ADAS-Cog scale will be completed before treatment and at week 8 of treatment.|Activities of daily living (ADL), The ADL consists of the Physical self-maintenance scale (PSMS) and the Instrumental Activities of daily living Scale (IADL). Higher scores indicating lower ability., ADL scale will be completed before treatment and at week 8 of treatment.|Pittsburgh Sleep Quality Index (PSQI), The PSQI Scale is a standardized tool used to assess sleep quality and contains 7 sections covering the main aspects of sleep quality. Each section was scored on a scale of 0-3, and the overall score was 0-21, with higher scores indicating poorer sleep quality., PSQI will be completed before treatment and at week 8 of treatment.|Zarit Burden Interview(ZBI), The ZBI scale is a tool used to assess the degree of psychological and physical burden on caregivers caring for family members with cognitive impairment or chronic illness. The total score ranges from 0 to 88, with higher scores indicating higher caregiving burden., ZBI will be completed before treatment and at week 8 of treatment.