Prospective Registry of Electroacupuncture Treatment for Patients With Different Behavioral and Psycological Symptoms of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Neuropsychiatric Inventory (NPI)
研究概览
简要总结
This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.
详细描述
To establish a prospective case registration research platform aimed at treating mild to moderate Alzheimer's disease patients presenting with behavioral and psychological symptoms. This platform will document the electroacupuncture treatment process, conduct regular assessments using neuropsychiatric questionnaires (NPI) and the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Scale (ADAS-CGIC), and compare the effects of different parameters, treatment frequency, and duration of electroacupuncture on therapeutic outcomes for various behavioral and psychological symptoms in Alzheimer's disease patients. Furthermore, it aims to investigate the influencing factors of electroacupuncture treatment for behavioral and psychological symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for AD in the NIA-AA standard;
- •Clinical dementia rating scale ≤2 points;
- •Accompanied by at least one psychobehavioral symptom, NPI：frequency × degree ≥1 point;
- •Sign informed consent.
排除标准
- •1.There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
结局指标
主要结局
Neuropsychiatric Inventory (NPI)
时间窗: NPI will be performed before treatment and every month after treatment for up to 24 months
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.
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
时间窗: The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months
ADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient symptoms on the ADCS-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.
次要结局
未报告次要终点
研究者
Bao-Hui Jia
Director of rehabilitation Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences