Amnestic Mild Cognitive Impairment - aMCINCT06626828
The Effect of Electroacupuncture Treatment on Cognitive Function in Adults With Amnestic Mild Cognitive Impairment
A study testing Electroacupuncture in people with Amnestic Mild Cognitive Impairment - aMCI, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Amnestic Mild Cognitive Impairment - aMCI
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Apr 2024to 3 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Currently pregnant
- Received acupuncture treatment for aMCI within a month before baseline assessment
- Experienced severe allergy after receiving acupuncture treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture and Acupressure Treatment for Amnestic Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Being tested
- Electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
Disposable sterilized needles are inserted into selected acupoints at a depth of approximately 17-25 mm and an angle of 15-30° along the scalp. Acupoints are then stimulated by the SDZ-II electroacupuncture device, with a dilatational wave pattern at 4/20 Hz. The intensity of the stimulation was adjusted to the patient\'s tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | After sterilization, disposable sterilized needles (0.25 × 40 mm, Taichi disposable acupuncture needles, Suzhou Shenlong Medical Apparatus Company, Suzhou, China) are inserted by the Registered Chinese Medicine Practitioner (RCMP) into the acupoints of Shenting (GV24), left Benshen (GB13), right Benshen (GB13), Baihui (GV20), and Sishencong (EX-HN 1). Acupoints are then stimulated by the Huatuo SDZ-II electroacupuncture device. Receives: Device: Electroacupuncture |
| Control group | No intervention | Blank control group with no further intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Domain and total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) adjusted by age and education level
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.
Measured: From baseline to Week 6
Secondary outcomes (2)
Clinical Dementia Rating (CDR) Sum of Boxes
The CDR scale is a widely recognized and validated instrument used to assess the severity and stage of dementia by evaluating six key cognitive domains: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care (Huang et al., 2021; O'Bryant et al., 2008). The overall CDR score ranges from 0 (normal cognition) to 3 (severe dementia), with higher scores indicating worse cognitive function. Specifically, a CDR-SoB score of 0.5-4.0 (corresponding to the overall CDR scores of 0.5), 4.5 to 9.0 (corresponding to the overall CDR scores of 1), 9.5 to 15.5 (corresponding to the overall CDR scores of 2), and 16.0 to 18.0 (corresponding to the overall CDR scores of 3) indicates MCI, mild, moderate, and severe dementia, respectively.
Measured: From baseline to Week 6
Verbal Fluency Test
Verbal fluency was assessed by asking participants to recall as many words as possible within a specific semantic category in one minute, which serves as a measure of verbal executive function. For this study, animals and fruits were the categories used. The total number of words generated serves as the verbal fluency score, with higher scores indicating better verbal executive function. There is no predefined minimum or maximum for this test, but lower scores suggest impaired executive function and cognitive flexibility.
Measured: From baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start4 Apr 2024
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Amnestic Mild Cognitive Impairment - aMCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Min Li, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626828
- Sponsor's protocol ID
- REC/23-24/0234
- Status last verified
- Sep 2025
- First submitted
- 2 Oct 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that support the findings in the publication, including demographics, patient characteristics, and outcome assessment data, etc. The anonymized datasets are available upon reasonable request.
Publications
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.
PubMed 28400807Ma 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.
PubMed 36212046He 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.
PubMed 34054504Yin 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.
PubMed 36686535
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Acupressure Treatment for Amnestic Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06626828
- Acronym / sponsor ID
- REC/23-24/0234
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Device: ElectroacupunctureAfter sterilization, disposable sterilized needles (0.25 × 40 mm, Taichi disposable acupuncture needles, Suzhou Shenlong Medical Apparatus Company, Suzhou, China) are inserted by the Registered Chinese Medicine Practitioner (RCMP) into the acupoints of Shenting (GV24), left Benshen (GB13), right Benshen (GB13), Baihui (GV20), and Sishencong (EX-HN 1). Acupoints are then stimulated by the Huatuo SDZ-II electroacupuncture device. |
| Control group | No intervention | –Blank control group with no further intervention. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureDisposable sterilized needles are inserted into selected acupoints at a depth of approximately 17-25 mm and an angle of 15-30° along the scalp. Acupoints are then stimulated by the SDZ-II electroacupuncture device, with a dilatational wave pattern at 4/20 Hz. The intensity of the stimulation was adjusted to the patient\'s tolerance. | Device | Electroacupuncture group |
Primary outcome
Domain and total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) adjusted by age and education level
Time frame: 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.
2 secondary outcomes
Clinical Dementia Rating (CDR) Sum of Boxes
Time frame: From baseline to Week 6
Verbal Fluency Test
Time frame: From baseline to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 28400807Tan 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.
- Background: PubMed 36212046Ma 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.
- Background: PubMed 34054504He 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.
- Background: PubMed 36686535Yin 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.
- Individual participant dataSharing planned: Yes. All IPD that support the findings in the publication, including demographics, patient characteristics, and outcome assessment data, etc. The anonymized datasets are available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Amnestic Mild Cognitive Impairment - aMCI, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Domain and total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) adjusted by age and education level (time frame: From baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06626828, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.