DementiaNCT04305951
Combining Acupuncture and Acupressure for Dementia Elderly
A study testing Comprehensive acupuncture therapy (CAT) and Comfy Acupressure for the Elderly (CAE) in people with Dementia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is an assessor-blinded, randomized controlled trial. A total of 248 (anticipated) elderly people aged ≥65 years with a mild to moderate dementia will be recruited from local nursing and care homes. They will be randomly assigned to routine care, CAT, CAE, and CAT+CAE with n = 62 subjects in each group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Comprehensive acupuncture therapy (CAT) and Comfy Acupressure for the Elderly (CAE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Oct 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- have a clinical diagnosis of any type of dementia or met the criteria of major and mild neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and
- have mild to moderate dementia at a stage of 3-5 on the Global Deterioration Scale (GDS).
Who cannot join
- have of dementia with the stage below 3 or above 5 on the GDS;
- have severe skin lesions on acupuncture and acupressure areas;
- have significant bleeding tendency;
- have heart pacemaker or implantable cardioverter defibrillator;
- are currently receiving acupressure as a regular therapy;
- had a surgery on the head or neck;
- are currently receiving anti-coagulant treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Acupuncture and Acupressure for Dementia Elderly: an Assessor-blinded, Randomized Controlled Trial
This is an assessor-blinded, randomized controlled trial. A total of 248 (anticipated) elderly people aged ≥65 years with a mild to moderate dementia will be recruited from local nursing and care homes. They will be randomly assigned to routine care, CAT, CAE, and CAT+CAE with n = 62 subjects in each group. Subjects assigned to CAT, CAE, and CAT+CAE will respectively receive 2 sessions of CAT, 3 sessions of CAE, and a combination of both per week for 12 weeks. The primary outcome is the baseline-to-endpoint change in score of the Montreal Cognitive Assessment (MoCA). Secondary outcomes include various domains of MoCA, functional independence, psychological well-being, sleep quality, and level of pain. A generalized linear mixed-effect model will be used to compare outcomes over time among the four groups.
Read the detailed description
Currently, there are about 100,000 people aged 65 years and older who are suffering from clinically diagnosed dementia in Hong Kong (HK). With an ageing population, this number will increase to 280,000 by 2036. Most dementia elderly live in nursing homes and elderly daycare centers. Dementia is the major cause of disability and dependency in elderly people. It poses a significant burden on caregivers, families, and the public healthcare system. Patients with dementia not only have a wide range of cognitive impairment, but also develop a variety of frailty-related symptoms, mainly including physical and psychological frailty, such as musculoskeletal deterioration, neurological disorders, sleep, emotional, and even psychotic symptoms. The overall purpose of the management of dementia elderly is to reduce dementia- and frailty-caused adverse outcomes that increase disability, dependency, hospitalization, and long-term care admission. However, there is a dearth of effective interventions improving the quality of life of elderly with dementia. The development of holistic management strategies that not only prevent and slow cognitive deterioration, but also reduce various other symptoms is therefore highly desired.
Acupuncture has been widely used in the local clinical practice. Numerous studies have shown the benefits of acupuncture in reducing cognitive deterioration in patients with cognitive impairment and dementia and animal models. Acupuncture is also effective in improving physical disability, rigidity, gait, and postural balance in aging adults with stroke and Parkinson's disease. A large body of evidence further confirms the effectiveness of various acupuncture regimens in treating pain, fatigue, sleep disturbance, anxiety, and depression. On the other hand, it is well demonstrated that, as a convenient therapy, acupressure has particular benefits in alleviating sleep disturbance, anxiety, depression, and agitation in elderly with dementia. Acupressure also has positive effects on the recovery of motor function and daily activities of stroke patients. These studies suggest that acupuncture and acupressure could produce benefits for the elderly with dementia.
Most recently, we have completed three clinical trials that evaluated the efficacy of acupuncture treatment of vascular dementia; stroke-caused cognitive deterioration , and chemotherapy-induced cognitive impairment. All these trials have consistently revealed that acupuncture was effective in alleviating cognitive impairment. We also have shown the effectiveness of a caregiver-performed acupressure on the general quality of life in frail older people and self-administered acupressure for insomnia disorder. The caregiver-performed acupressure protocol is called 'Comfy Acupressure for the Elderly (CAE)' and demonstration video is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM. Furthermore, our several studies have confirmed the efficacy of acupuncture in improving major depression ; insomnia and anxiety, poststroke depression and movement disability. Meanwhile, we have developed a novel acupuncture mode called comprehensive acupuncture therapy (CAT) that consists of dense frontal acupoints with additional electrical stimulation and multiple body acupoints. The efficacy of CAT has been well proven in our previous studies.
The working hypothesis is that CAT and CAE are feasible, safe, and could produce better management outcomes than routine care in improving cognitive impairment, frailty-related disability and dependency as well as comorbid symptoms of aged people with dementia. The aims of this study are: (1) to determine whether the conditions of cognitive impairment in the treatment groups improve significantly when compared to control; (2) to determine whether other symptoms (e.g., functional independence, pain, depression, and sleep disorder) in the treatment groups improve more than in control; and (3) to investigate whether acupuncture or acupressure is safe for the elderly with cognitive impairment or dementia.
- Conditions
- Dementia
- Being tested
- Comprehensive acupuncture therapy (CAT), Comfy Acupressure for the Elderly (CAE)
- Keywords
- Dementia, Cognitive impairment, Elderly, Acupuncture, CAT, Acupressure, CAE
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive acupuncture therapy (CAT)Procedure or surgery
CAT will be conducted for 2 sessions per week for 12 consecutive weeks.
The following 14 body acupoints with only manual stimulation will be used: HT7 (Shenmen), LI4 (Hegu), TH5 (Waiguan), ST36 (Zusanli), ST40 (Fenglong) and SP6 (Sanyinjiao) in two sides, and CV12 (Zhongwan) and CV4 (Guanyuan) in midline. Electrical stimulation will be conducted on the following frontal acupoints: GV20 (Baihui), EX-HN3 (Yintang), GB15 (Toulinqi), GB8 (Shuaigu), EX-HN5 (Taiyang), and ST8 (Touwei) on two sides, and left and right EX-HN1 (Sishencong).
Disposable acupuncture needles (0.25 mm in diameter and 25-40 mm in length) will be inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation is additionally delivered on the 6 pairs of the frontal acupoints. Each session of treatment will last 30 minutes.
Comfy Acupressure for the Elderly (CAE)Procedure or surgery
CAE intervention will be conducted for 3 times per week for 12 consecutive weeks.
CAE consists of 12 steps which need about 15 minutes to complete and mainly concentrates on the acupoints on face, head, neck, and shoulder. The detailed CAE Operation Guide will be provided for the provider and the video demonstration is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM.
| Study group | Role | What they receive |
|---|---|---|
| Routine care group | No intervention | Subjects assigned to this group will continue their routine care without receiving any acupuncture and acupressure treatment during the study period. The routine care may include physiotherapy and intellectual activities. Post-trial treatment of either CAT, CAE, or CAT+CAE will be offered to serve as a compensation for their participation. |
| CAT group | Experimental | Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care. Receives: Procedure: Comprehensive acupuncture therapy (CAT) |
| CAE group | Experimental | Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care. Receives: Procedure: Comfy Acupressure for the Elderly (CAE) |
| CAT + CAE group | Experimental | Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care. Receives: Procedure: Comprehensive acupuncture therapy (CAT); Procedure: Comfy Acupressure for the Elderly (CAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Montreal Cognitive Assessment Score
Severity of dementia is primarily measured using Montreal Cognitive Assessment (MoCA) and its overall score ranges from 0 to 30. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Secondary outcomes (6)
Change in the Digit Span Forward
Severity of dementia is measured using Digit Span Forward and its overall score ranges from 0 to 14. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Change in the Digit Span Reverse
Severity of dementia is measured using Digit Span Reverse and its overall score ranges from 0 to 14. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Changes in the Modified Bathel Index Score
Functional independence is measured using Modified Bathel Index (MBI) and its overall score ranges from 10 to 50. A higher score indicates better functional independence. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Changes in the Visual Analogue Scale Score
Pain is evaluated using visual analogue scale (VAS) and its overall score ranges from 0 to 10. A higher score indicates greater severity. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Changes in the Geriatric Depression Scale Score
Depressive symptoms are measured using the 15-item Geriatric Depression Scale (GDS-15) and its overall score ranges from 0 to 15. A higher score indicates greater severity. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Changes in the Insomnia Severity Index Score
Sleep parameters are measured using Insomnia Severity Index (ISI) and its overall score ranges from 0 to 28. A higher score indicates more acute sleep disturbances. Assessments will be conducted at baseline and once every six weeks thereafter.
Measured: Baseline, 6 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start5 Oct 2021
- Primary completion27 Aug 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Zhang Zhang-Jin, The University of Hong Kong
- Investigators
- Zhang-Jin Zhang, MMed, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305951
- Sponsor's protocol ID
- UW 19-821
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2020
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan CWC, Chau PH, Leung AYM, Lo KC, Shi H, Yum TP, Lee YY, Li L. Acupressure for frail older people in community dwellings-a randomised controlled trial. Age Ageing. 2017 Nov 1;46(6):957-964. doi: 10.1093/ageing/afx050.
PubMed 28472415Chung KF, Yeung WF, Yu BY, Leung FC, Zhang SP, Zhang ZJ, Ng RM, Yiu GC. Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial. Acupunct Med. 2018 Feb;36(1):2-13. doi: 10.1136/acupmed-2017-011371. Epub 2017 Dec 11.
PubMed 29229613Hmwe NTT, Browne G, Mollart L, Allanson V, Chan SW. An integrative review of acupressure interventions for older people: A focus on sleep quality, depression, anxiety, and agitation. Int J Geriatr Psychiatry. 2019 Mar;34(3):381-396. doi: 10.1002/gps.5031. Epub 2018 Dec 10.
PubMed 30430640Kwan RYC, Leung MCP, Lai CKY. A Randomized Controlled Trial Examining the Effect of Acupressure on Agitation and Salivary Cortisol in Nursing Home Residents with Dementia. Dement Geriatr Cogn Disord. 2017;44(1-2):92-104. doi: 10.1159/000478739. Epub 2017 Jul 29.
PubMed 28768251Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255.
PubMed 25038733Margenfeld F, Klocke C, Joos S. Manual massage for persons living with dementia: A systematic review and meta-analysis. Int J Nurs Stud. 2019 Aug;96:132-142. doi: 10.1016/j.ijnurstu.2018.12.012. Epub 2019 Jan 4.
PubMed 30679034Qu SS, Huang Y, Zhang ZJ, Chen JQ, Lin RY, Wang CQ, Li GL, Wong HK, Zhao CH, Pan JY, Guo SC, Zhang YC. A 6-week randomized controlled trial with 4-week follow-up of acupuncture combined with paroxetine in patients with major depressive disorder. J Psychiatr Res. 2013 Jun;47(6):726-32. doi: 10.1016/j.jpsychires.2013.02.004. Epub 2013 Mar 14.
PubMed 23498306Simoncini M, Gatti A, Quirico PE, Balla S, Capellero B, Obialero R, D'Agostino S, Sandri N, Pernigotti LM. Acupressure in insomnia and other sleep disorders in elderly institutionalized patients suffering from Alzheimer's disease. Aging Clin Exp Res. 2015 Feb;27(1):37-42. doi: 10.1007/s40520-014-0244-9. Epub 2014 May 31.
PubMed 24878886Toosizadeh N, Lei H, Schwenk M, Sherman SJ, Sternberg E, Mohler J, Najafi B. Does integrative medicine enhance balance in aging adults? Proof of concept for the benefit of electroacupuncture therapy in Parkinson's disease. Gerontology. 2015;61(1):3-14. doi: 10.1159/000363442. Epub 2014 Oct 22.
PubMed 25341431Wang S, Yang H, Zhang J, Zhang B, Liu T, Gan L, Zheng J. Efficacy and safety assessment of acupuncture and nimodipine to treat mild cognitive impairment after cerebral infarction: a randomized controlled trial. BMC Complement Altern Med. 2016 Sep 13;16(1):361. doi: 10.1186/s12906-016-1337-0.
PubMed 27623621Wu YT, Ali GC, Guerchet M, Prina AM, Chan KY, Prince M, Brayne C. Prevalence of dementia in mainland China, Hong Kong and Taiwan: an updated systematic review and meta-analysis. Int J Epidemiol. 2018 Jun 1;47(3):709-719. doi: 10.1093/ije/dyy007.
PubMed 29444280Yang A, Wu HM, Tang JL, Xu L, Yang M, Liu GJ. Acupuncture for stroke rehabilitation. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD004131. doi: 10.1002/14651858.CD004131.pub3.
PubMed 27562656Yang JW, Shi GX, Zhang S, Tu JF, Wang LQ, Yan CQ, Lin LL, Liu BZ, Wang J, Sun SF, Yang BF, Wu LY, Tan C, Chen S, Zhang ZJ, Fisher M, Liu CZ. Effectiveness of acupuncture for vascular cognitive impairment no dementia: a randomized controlled trial. Clin Rehabil. 2019 Apr;33(4):642-652. doi: 10.1177/0269215518819050. Epub 2019 Jan 23.
PubMed 30672317Yang MH, Lin LC, Wu SC, Chiu JH, Wang PN, Lin JG. Comparison of the efficacy of aroma-acupressure and aromatherapy for the treatment of dementia-associated agitation. BMC Complement Altern Med. 2015 Mar 29;15:93. doi: 10.1186/s12906-015-0612-9.
PubMed 25880034Yeung WF, Chung KF, Tso KC, Zhang SP, Zhang ZJ, Ho LM. Electroacupuncture for residual insomnia associated with major depressive disorder: a randomized controlled trial. Sleep. 2011 Jun 1;34(6):807-15. doi: 10.5665/SLEEP.1056.
PubMed 21629370
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Acupuncture and Acupressure for Dementia Elderly: an Assessor-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04305951
- Acronym / sponsor ID
- UW 19-821
- Conditions
- Dementia
- Keywords
- Dementia, Cognitive impairment, Elderly, Acupuncture, CAT, Acupressure, CAE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an assessor-blinded, randomized controlled trial. A total of 248 (anticipated) elderly people aged ≥65 years with a mild to moderate dementia will be recruited from local nursing and care homes. They will be randomly assigned to routine care, CAT, CAE, and CAT+CAE with n = 62 subjects in each group. Subjects assigned to CAT, CAE, and CAT+CAE will respectively receive 2 sessions of CAT, 3 sessions of CAE, and a combination of both per week for 12 weeks. The primary outcome is the baseline-to-endpoint change in score of the Montreal Cognitive Assessment (MoCA). Secondary outcomes include various domains of MoCA, functional independence, psychological well-being, sleep quality, and level of pain. A generalized linear mixed-effect model will be used to compare outcomes over time among the four groups.
Detailed description
Currently, there are about 100,000 people aged 65 years and older who are suffering from clinically diagnosed dementia in Hong Kong (HK). With an ageing population, this number will increase to 280,000 by 2036. Most dementia elderly live in nursing homes and elderly daycare centers. Dementia is the major cause of disability and dependency in elderly people. It poses a significant burden on caregivers, families, and the public healthcare system. Patients with dementia not only have a wide range of cognitive impairment, but also develop a variety of frailty-related symptoms, mainly including physical and psychological frailty, such as musculoskeletal deterioration, neurological disorders, sleep, emotional, and even psychotic symptoms. The overall purpose of the management of dementia elderly is to reduce dementia- and frailty-caused adverse outcomes that increase disability, dependency, hospitalization, and long-term care admission. However, there is a dearth of effective interventions improving the quality of life of elderly with dementia. The development of holistic management strategies that not only prevent and slow cognitive deterioration, but also reduce various other symptoms is therefore highly desired.
Acupuncture has been widely used in the local clinical practice. Numerous studies have shown the benefits of acupuncture in reducing cognitive deterioration in patients with cognitive impairment and dementia and animal models. Acupuncture is also effective in improving physical disability, rigidity, gait, and postural balance in aging adults with stroke and Parkinson's disease. A large body of evidence further confirms the effectiveness of various acupuncture regimens in treating pain, fatigue, sleep disturbance, anxiety, and depression. On the other hand, it is well demonstrated that, as a convenient therapy, acupressure has particular benefits in alleviating sleep disturbance, anxiety, depression, and agitation in elderly with dementia. Acupressure also has positive effects on the recovery of motor function and daily activities of stroke patients. These studies suggest that acupuncture and acupressure could produce benefits for the elderly with dementia.
Most recently, we have completed three clinical trials that evaluated the efficacy of acupuncture treatment of vascular dementia; stroke-caused cognitive deterioration , and chemotherapy-induced cognitive impairment. All these trials have consistently revealed that acupuncture was effective in alleviating cognitive impairment. We also have shown the effectiveness of a caregiver-performed acupressure on the general quality of life in frail older people and self-administered acupressure for insomnia disorder. The caregiver-performed acupressure protocol is called 'Comfy Acupressure for the Elderly (CAE)' and demonstration video is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM. Furthermore, our several studies have confirmed the efficacy of acupuncture in improving major depression ; insomnia and anxiety, poststroke depression and movement disability. Meanwhile, we have developed a novel acupuncture mode called comprehensive acupuncture therapy (CAT) that consists of dense frontal acupoints with additional electrical stimulation and multiple body acupoints. The efficacy of CAT has been well proven in our previous studies.
The working hypothesis is that CAT and CAE are feasible, safe, and could produce better management outcomes than routine care in improving cognitive impairment, frailty-related disability and dependency as well as comorbid symptoms of aged people with dementia. The aims of this study are: (1) to determine whether the conditions of cognitive impairment in the treatment groups improve significantly when compared to control; (2) to determine whether other symptoms (e.g., functional independence, pain, depression, and sleep disorder) in the treatment groups improve more than in control; and (3) to investigate whether acupuncture or acupressure is safe for the elderly with cognitive impairment or dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Routine care group | No intervention | –Subjects assigned to this group will continue their routine care without receiving any acupuncture and acupressure treatment during the study period. The routine care may include physiotherapy and intellectual activities. Post-trial treatment of either CAT, CAE, or CAT+CAE will be offered to serve as a compensation for their participation. |
| CAT group | Experimental | Procedure: Comprehensive acupuncture therapy (CAT)Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care. |
| CAE group | Experimental | Procedure: Comfy Acupressure for the Elderly (CAE)Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care. |
| CAT + CAE group | Experimental | Procedure: Comprehensive acupuncture therapy (CAT), Procedure: Comfy Acupressure for the Elderly (CAE)Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- have a clinical diagnosis of any type of dementia or met the criteria of major and mild neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and
- have mild to moderate dementia at a stage of 3-5 on the Global Deterioration Scale (GDS).
Key exclusion criteria (7 listed)
- have of dementia with the stage below 3 or above 5 on the GDS;
- have severe skin lesions on acupuncture and acupressure areas;
- have significant bleeding tendency;
- have heart pacemaker or implantable cardioverter defibrillator;
- are currently receiving acupressure as a regular therapy;
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 |
|---|---|---|
| Comprehensive acupuncture therapy (CAT)CAT will be conducted for 2 sessions per week for 12 consecutive weeks. The following 14 body acupoints with only manual stimulation will be used: HT7 (Shenmen), LI4 (Hegu), TH5 (Waiguan), ST36 (Zusanli), ST40 (Fenglong) and SP6 (Sanyinjiao) in two sides, and CV12 (Zhongwan) and CV4 (Guanyuan) in midline. Electrical stimulation will be conducted on the following frontal acupoints: GV20 (Baihui), EX-HN3 (Yintang), GB15 (Toulinqi), GB8 (Shuaigu), EX-HN5 (Taiyang), and ST8 (Touwei) on two sides, and left and right EX-HN1 (Sishencong). Disposable acupuncture needles (0.25 mm in diameter and 25-40 mm in length) will be inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation is additionally delivered on the 6 pairs of the frontal acupoints. Each session of treatment will last 30 minutes. | Procedure or surgery | CAT + CAE group, CAT group |
| Comfy Acupressure for the Elderly (CAE)CAE intervention will be conducted for 3 times per week for 12 consecutive weeks. CAE consists of 12 steps which need about 15 minutes to complete and mainly concentrates on the acupoints on face, head, neck, and shoulder. The detailed CAE Operation Guide will be provided for the provider and the video demonstration is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM. | Procedure or surgery | CAE group, CAT + CAE group |
Primary outcome
Changes in the Montreal Cognitive Assessment Score
Time frame: Baseline, 6 week, 12 week
Severity of dementia is primarily measured using Montreal Cognitive Assessment (MoCA) and its overall score ranges from 0 to 30. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.
6 secondary outcomes
Change in the Digit Span Forward
Time frame: Baseline, 6 week, 12 week
Change in the Digit Span Reverse
Time frame: Baseline, 6 week, 12 week
Changes in the Modified Bathel Index Score
Time frame: Baseline, 6 week, 12 week
Changes in the Visual Analogue Scale Score
Time frame: Baseline, 6 week, 12 week
Changes in the Geriatric Depression Scale Score
Time frame: Baseline, 6 week, 12 week
Changes in the Insomnia Severity Index Score
Time frame: Baseline, 6 week, 12 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28472415Chan CWC, Chau PH, Leung AYM, Lo KC, Shi H, Yum TP, Lee YY, Li L. Acupressure for frail older people in community dwellings-a randomised controlled trial. Age Ageing. 2017 Nov 1;46(6):957-964. doi: 10.1093/ageing/afx050.
- Background: PubMed 29229613Chung KF, Yeung WF, Yu BY, Leung FC, Zhang SP, Zhang ZJ, Ng RM, Yiu GC. Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial. Acupunct Med. 2018 Feb;36(1):2-13. doi: 10.1136/acupmed-2017-011371. Epub 2017 Dec 11.
- Background: PubMed 30430640Hmwe NTT, Browne G, Mollart L, Allanson V, Chan SW. An integrative review of acupressure interventions for older people: A focus on sleep quality, depression, anxiety, and agitation. Int J Geriatr Psychiatry. 2019 Mar;34(3):381-396. doi: 10.1002/gps.5031. Epub 2018 Dec 10.
- Background: PubMed 28768251Kwan RYC, Leung MCP, Lai CKY. A Randomized Controlled Trial Examining the Effect of Acupressure on Agitation and Salivary Cortisol in Nursing Home Residents with Dementia. Dement Geriatr Cogn Disord. 2017;44(1-2):92-104. doi: 10.1159/000478739. Epub 2017 Jul 29.
- Background: PubMed 25038733Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255.
- Background: PubMed 30679034Margenfeld F, Klocke C, Joos S. Manual massage for persons living with dementia: A systematic review and meta-analysis. Int J Nurs Stud. 2019 Aug;96:132-142. doi: 10.1016/j.ijnurstu.2018.12.012. Epub 2019 Jan 4.
- Background: PubMed 23498306Qu SS, Huang Y, Zhang ZJ, Chen JQ, Lin RY, Wang CQ, Li GL, Wong HK, Zhao CH, Pan JY, Guo SC, Zhang YC. A 6-week randomized controlled trial with 4-week follow-up of acupuncture combined with paroxetine in patients with major depressive disorder. J Psychiatr Res. 2013 Jun;47(6):726-32. doi: 10.1016/j.jpsychires.2013.02.004. Epub 2013 Mar 14.
- Background: PubMed 24878886Simoncini M, Gatti A, Quirico PE, Balla S, Capellero B, Obialero R, D'Agostino S, Sandri N, Pernigotti LM. Acupressure in insomnia and other sleep disorders in elderly institutionalized patients suffering from Alzheimer's disease. Aging Clin Exp Res. 2015 Feb;27(1):37-42. doi: 10.1007/s40520-014-0244-9. Epub 2014 May 31.
- Background: PubMed 25341431Toosizadeh N, Lei H, Schwenk M, Sherman SJ, Sternberg E, Mohler J, Najafi B. Does integrative medicine enhance balance in aging adults? Proof of concept for the benefit of electroacupuncture therapy in Parkinson's disease. Gerontology. 2015;61(1):3-14. doi: 10.1159/000363442. Epub 2014 Oct 22.
- Background: PubMed 27623621Wang S, Yang H, Zhang J, Zhang B, Liu T, Gan L, Zheng J. Efficacy and safety assessment of acupuncture and nimodipine to treat mild cognitive impairment after cerebral infarction: a randomized controlled trial. BMC Complement Altern Med. 2016 Sep 13;16(1):361. doi: 10.1186/s12906-016-1337-0.
- Background: PubMed 29444280Wu YT, Ali GC, Guerchet M, Prina AM, Chan KY, Prince M, Brayne C. Prevalence of dementia in mainland China, Hong Kong and Taiwan: an updated systematic review and meta-analysis. Int J Epidemiol. 2018 Jun 1;47(3):709-719. doi: 10.1093/ije/dyy007.
- Background: PubMed 27562656Yang A, Wu HM, Tang JL, Xu L, Yang M, Liu GJ. Acupuncture for stroke rehabilitation. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD004131. doi: 10.1002/14651858.CD004131.pub3.
- Individual participant dataSharing planned: No
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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.
Zhang-Jin Zhang, MMed, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive acupuncture therapy (CAT) and Comfy Acupressure for the Elderly (CAE) in people with Dementia, run by The University of Hong Kong 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 2 inclusion and 7 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 10 Feb 2026. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in the Montreal Cognitive Assessment Score (time frame: Baseline, 6 week, 12 week). 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 NCT04305951, which also lists 20 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 10 Feb 2026.