Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 7
- 主要终点
- Cohen Mansfield Agitation Inventory (CMAI)
研究概览
简要总结
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.
详细描述
This is a multicenter, parallel-group, patient-blinded and outcome-assessor-blinded randomized controlled trial consisting of two stages: a 8-week treatment period followed by a 8-week follow-up period. The study aims to assess therapeutic efficacy and safety of electroacupuncture for agitated symptoms of AD. Approximately 224 AD patients with symptoms of agitation will be randomly assigned to the electroacupuncture group or micro-electroacupuncture group. 50 patients in each of the two groups will be selected to complete rs-fMRI scans before the initial treatment and after the last treatment in order to investigate the central mechanism underlying the effects of electroacupuncture treatment on functional activity in patients with AD patients with symptoms of agitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •If taking antipsychotics, the medication regimen for agitation (antipsychotics) is stable for 1 month prior to randomization
- •Subject and legal guardian and caregiver sign informed consent.
排除标准
- •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.
结局指标
主要结局
Cohen Mansfield Agitation Inventory (CMAI)
时间窗: CMAI will be evaluated after the final treatment at week 8
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.
次要结局
- Cohen Mansfield Agitation Inventory (CMAI)(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)(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 assessment will be completed before treatment and at week 8 of treatment.)
- Neuropsychiatric Inventory (NPI)(NPI will be completed before treatment and at week 8 of treatment.)
- Mini-mental State Examination (MMSE)(MMSE will be completed before treatment and at week 8 of treatment.)
- Alzheimer disease assessment scale cognition (ADAS-Cog)(ADAS-Cog scale will be completed before treatment and at week 8 of treatment.)
- Activities of daily living (ADL)(ADL scale will be completed before treatment and at week 8 of treatment.)
- Pittsburgh Sleep Quality Index (PSQI)(PSQI will be completed before treatment and at week 8 of treatment.)
- Zarit Burden Interview(ZBI)(ZBI will be completed before treatment and at week 8 of treatment.)
研究者
Bao-Hui Jia
Director of rehabilitation Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences