Clinical trial NCT06626828: The Effect of Electroacupuncture Treatment on Cognitive Function in Adults with Amnestic Mild Cognitive Impairment
Official title: Acupuncture and Acupressure Treatment for Amnestic Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amnestic Mild Cognitive Impairment - AMCI
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Amnestic mild cognitive impairment (aMCI) is a prevalent condition, often regarded as the transitional phase between normal cognitive aging and early Alzheimer\&amp;#39;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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with an aMCI according to the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
2. With a Clinical Dementia Scale (CDR) score of 0.5, with the memory domain larger than 0
3. Within the age range of 55 to 75 years old
4. With visual and auditory acuity adequate for neuropsychological testing
5. Under a stable medical condition for 3 months prior to screening and baseline assessment
6. Under stable medications for 4 weeks before screening and baseline assessment

Exclusion Criteria:

1. 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.
2. With concurrent depression, anxiety, or suicidal thoughts within the past year
3. With concurrent major neurological conditions, including stroke, epilepsy and seizures, etc.
4. Currently immunocompromised due to receiving treatment for tumor, receiving immunosuppressive therapy, primary immunodeficiency, HIV infection, receiving high dose corticosteroids, etc
5. With bleeding disorders, including hemophilia, von Willebrand disease, vitamin K deficiency, etc.
6. With active neoplastic disease
7. Currently pregnant
8. Received acupuncture treatment for aMCI within a month before baseline assessment
9. Experienced severe allergy after receiving acupuncture treatment

Primary outcomes:
measure: Domain and total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) adjusted by age and education level
timeFrame: From baseline to Week 6
Secondary outcomes:
measure: Total score and memory domain score of the Clinical Dementia Rating (CDR) Scale
timeFrame: From baseline to Week 6
measure: Verbal Fluency Test
timeFrame: From baseline to Week 6
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Baptist University
Study officials:
References:
citation: Tan TT, Wang D, Huang JK, Zhou XM, Yuan X, Liang JP, Yin L, Xie HL, Jia XY, Shi J, Wang F, Yang HB, Chen SJ. Modulatory effects of acupuncture on brain networks in mild cognitive impairment patients. Neural Regen Res. 2017 Feb;12(2):250-258. doi: 10.4103/1673-5374.200808.
citation: Ma S, Huang H, Zhong Z, Zheng H, Li M, Yao L, Yu B, Wang H. Effect of acupuncture on brain regions modulation of mild cognitive impairment: A meta-analysis of functional magnetic resonance imaging studies. Front Aging Neurosci. 2022 Sep 23;14:914049. doi: 10.3389/fnagi.2022.914049. eCollection 2022.
citation: He W, Li M, Han X, Zhang W. Acupuncture for Mild Cognitive Impairment and Dementia: An Overview of Systematic Reviews. Front Aging Neurosci. 2021 May 14;13:647629. doi: 10.3389/fnagi.2021.647629. eCollection 2021.
citation: Yin Z, Li Y, Jiang C, Xia M, Chen Z, Zhang X, Zhao L, Liang F. Acupuncture for mild cognitive impairment: A systematic review with meta-analysis and trial sequential analysis. Front Neurol. 2023 Jan 6;13:1091125. doi: 10.3389/fneur.2022.1091125. eCollection 2022.