Acupuncture and Acupressure Treatment for Amnestic Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Domain and total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) adjusted by age and education level
研究概览
简要总结
Background:
Amnestic mild cognitive impairment (aMCI) is a prevalent condition, often regarded as the transitional phase between normal cognitive aging and early Alzheimer's disease. Conventional treatments for aMCI remain limited, with pharmacological interventions showing mixed results and often failing to halt disease progression. Electroacupuncture (EA), is believed to improve cognitive function in various neurodegenerative disorders, including aMCI. Randomized controlled trials have also reported that acupuncture can positively influence cognitive function by promoting cerebral blood flow and modulating neurotransmitter activity, potentially offering a non-pharmacological approach to managing aMCI. However, robust clinical trials are lacking, and there is a need to assess the feasibility and efficacy of EA in treating aMCI. This pilot study aims to determine the preliminary efficacy of EA in improving cognitive function, and to evaluate the feasibility of the study design for future large-scale trials.
Methods:
This trial will be a multicenter, assessor- and data analyst-blind, pilot randomized controlled trial. A total of 24 participants aged 55-75 years, diagnosed with aMCI, will be recruited and randomly assigned in a 1:1 ratio into either the EA treatment group or a control group. Participants in the EA group will receive electroacupuncture at specific acupoints, while the control group will not undergo any intervention. The intervention will last 4 weeks, with two EA sessions per week, a total of 8 sessions. Assessments will be conducted at three time points: baseline, post-treatment (Week 4), and follow-up (Week 6). All participants will continue their standard medical care throughout the trial.
The primary outcome will be the change in cognitive function as measured by the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA). Secondary outcomes will include changes in the Clinical Dementia Rating (CDR) and verbal fluency test, focusing on the memory domain. Safety and adverse events will be monitored throughout the study via follow-up assessments and questionnaires. Statistical analyses, including linear mixed models (LMM), will be performed using R and SPSS software, adhering to the intention-to-treat principle.
Expected Outcomes:
This pilot study is expected to provide preliminary data on the efficacy and safety of electroacupuncture in improving cognitive function in patients with aMCI. It will also assess the feasibility of conducting a larger-scale trial, including participant recruitment, adherence to the intervention, and the acceptability of outcome measures. Findings from this study will offer insights into the therapeutic potential of acupuncture and inform the design of future trials aimed at exploring its role as an alternative or complementary treatment for aMCI.
详细描述
Ethical Considerations
Ethical approval for this study has been obtained from the Research Ethics Committee of Hong Kong Baptist University (REC/23-24/0234). All participants will provide written informed consent before enrollment, and their confidentiality and safety will be prioritized throughout the study.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with an aMCI according to the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
- •With a Clinical Dementia Scale (CDR) score of 0.5, with the memory domain larger than 0
- •Within the age range of 55 to 75 years old
- •With visual and auditory acuity adequate for neuropsychological testing
- •Under a stable medical condition for 3 months prior to screening and baseline assessment
- •Under stable medications for 4 weeks before screening and baseline assessment
排除标准
- •With concurrent conditions that could contribute to the cognitive deficits, including any type of dementia including Alzheimer disease, vascular dementia, or any major psychiatric disorders such as major depressive disorder, schizophrenia, delirium, psychosis, etc.
- •With concurrent depression, anxiety, or suicidal thoughts within the past year
- •With concurrent major neurological conditions, including stroke, epilepsy and seizures, etc.
- •Currently immunocompromised due to receiving treatment for tumor, receiving immunosuppressive therapy, primary immunodeficiency, HIV infection, receiving high dose corticosteroids, etc
- •With bleeding disorders, including hemophilia, von Willebrand disease, vitamin K deficiency, etc.
- •With active neoplastic disease
- •Currently pregnant
- •Received acupuncture treatment for aMCI within a month before baseline assessment
- •Experienced severe allergy after receiving acupuncture treatment
结局指标
主要结局
Domain and total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) adjusted by age and education level
时间窗: From baseline to Week 6
Comprehensively evaluates multiple cognitive domains, including memory recall, visuospatial ability, language, attention, concentration, executive function, and orientation to time and space. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores are adjusted by age and education level. To mitigate the potential for practice effects, an alternate version of the HK-MoCA was employed during follow-up assessments.
次要结局
- Verbal Fluency Test(From baseline to Week 6)
- Clinical Dementia Rating (CDR) Sum of Boxes(From baseline to Week 6)
- Verbal Fluency Test(From baseline to Week 6)
研究者
Prof Min Li
Dean and Chair Professor, School of Chinese Medicine
Hong Kong Baptist University