Trial Outcomes & Findings for Combining Acupuncture and Acupressure for Dementia Elderly (NCT NCT04305951)

NCT ID: NCT04305951

Last Updated: 2026-02-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

236 participants

Primary outcome timeframe

Baseline, 6 week, 12 week

Results posted on

2026-02-10

Participant Flow

Recruitment and treatment started in October 2021 and ended in August 2024. Elderly people with cognitive impairment or dementia of any type were recruited in 19 local elderly care homes, with 6 in Hong Kong Island, 9 in Kowloon and 4 in New Territories.

Participant milestones

Participant milestones
Measure
Routine Care Group
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
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
CAE Group
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Overall Study
STARTED
59
59
59
59
Overall Study
COMPLETED
55
46
51
49
Overall Study
NOT COMPLETED
4
13
8
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Total
n=236 Participants
Total of all reporting groups
Age, Continuous
85.3 year
STANDARD_DEVIATION 7.2 • n=59 Participants
82.6 year
STANDARD_DEVIATION 8.8 • n=59 Participants
84.8 year
STANDARD_DEVIATION 8.7 • n=59 Participants
84.6 year
STANDARD_DEVIATION 8.6 • n=59 Participants
84.3 year
STANDARD_DEVIATION 8.3 • n=236 Participants
Sex: Female, Male
Female
41 Participants
n=59 Participants
30 Participants
n=59 Participants
35 Participants
n=59 Participants
31 Participants
n=59 Participants
137 Participants
n=236 Participants
Sex: Female, Male
Male
18 Participants
n=59 Participants
29 Participants
n=59 Participants
24 Participants
n=59 Participants
28 Participants
n=59 Participants
99 Participants
n=236 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
MoCA
8.8 score
STANDARD_DEVIATION 5.9 • n=59 Participants
10.5 score
STANDARD_DEVIATION 7.3 • n=59 Participants
10.9 score
STANDARD_DEVIATION 7.3 • n=59 Participants
10.1 score
STANDARD_DEVIATION 6.3 • n=59 Participants
10.1 score
STANDARD_DEVIATION 6.7 • n=236 Participants

PRIMARY outcome

Timeframe: Baseline, 6 week, 12 week

Population: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.

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.

Outcome measures

Outcome measures
Measure
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Changes in the Montreal Cognitive Assessment Score
Week 6
1.06 score
Interval 0.13 to 1.99
0.44 score
Interval -0.37 to 1.25
0.14 score
Interval -0.75 to 1.02
0.70 score
Interval -0.18 to 1.59
Changes in the Montreal Cognitive Assessment Score
Week 12
1.33 score
Interval 0.4 to 2.26
0.40 score
Interval -0.44 to 1.23
-0.25 score
Interval -1.11 to 0.62
0.60 score
Interval -0.28 to 1.49

SECONDARY outcome

Timeframe: Baseline, 6 week, 12 week

Population: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.

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.

Outcome measures

Outcome measures
Measure
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Change in the Digit Span Forward
Week 6
0.01 score
Interval -0.68 to 0.7
0.37 score
Interval -0.28 to 1.01
0.04 score
Interval -1.01 to 1.09
-0.15 score
Interval -0.97 to 0.67
Change in the Digit Span Forward
Week 12
-0.01 score
Interval -0.71 to 0.68
0.30 score
Interval -0.37 to 0.97
-1.59 score
Interval -2.61 to -0.56
-0.61 score
Interval -1.43 to 0.21

SECONDARY outcome

Timeframe: Baseline, 6 week, 12 week

Population: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.

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.

Outcome measures

Outcome measures
Measure
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Change in the Digit Span Reverse
Week 6
0.10 score
Interval -0.36 to 0.57
0.15 score
Interval -0.35 to 0.65
-0.04 score
Interval -0.53 to 0.44
-0.43 score
Interval -0.92 to 0.07
Change in the Digit Span Reverse
Week 12
0.47 score
Interval 0.0 to 0.94
0.23 score
Interval -0.28 to 0.74
-0.23 score
Interval -0.7 to 0.25
0.02 score
Interval -0.48 to 0.51

SECONDARY outcome

Timeframe: Baseline, 6 week, 12 week

Population: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.

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.

Outcome measures

Outcome measures
Measure
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Changes in the Modified Bathel Index Score
Week 6
0.94 score
Interval -0.61 to 2.49
0.68 score
Interval -1.12 to 2.48
0.82 score
Interval -1.33 to 2.96
1.97 score
Interval -0.5 to 4.43
Changes in the Modified Bathel Index Score
Week 12
0.57 score
Interval -1.0 to 2.13
1.82 score
Interval -0.02 to 3.67
-0.93 score
Interval -3.04 to 1.17
3.11 score
Interval 0.63 to 5.59

SECONDARY outcome

Timeframe: Baseline, 6 week, 12 week

Population: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.

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.

Outcome measures

Outcome measures
Measure
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Changes in the Visual Analogue Scale Score
Week 6
0.01 score
Interval -0.65 to 0.67
-0.57 score
Interval -1.2 to 0.06
0.11 score
Interval -0.6 to 0.81
-0.43 score
Interval -1.09 to 0.23
Changes in the Visual Analogue Scale Score
Week 12
-0.49 score
Interval -1.17 to 0.18
-0.32 score
Interval -0.97 to 0.33
-0.18 score
Interval -0.87 to 0.51
-0.23 score
Interval -0.9 to 0.44

SECONDARY outcome

Timeframe: Baseline, 6 week, 12 week

Population: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.

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.

Outcome measures

Outcome measures
Measure
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Changes in the Geriatric Depression Scale Score
Week 6
-1.23 score
Interval -2.32 to -0.13
-0.62 score
Interval -1.53 to 0.3
-0.49 score
Interval -1.7 to 0.71
-0.67 score
Interval -1.73 to 0.4
Changes in the Geriatric Depression Scale Score
Week 12
-1.85 score
Interval -2.99 to -0.72
-0.75 score
Interval -1.67 to 0.18
-1.47 score
Interval -2.68 to -0.26
-0.39 score
Interval -1.45 to 0.66

SECONDARY outcome

Timeframe: Baseline, 6 week, 12 week

Population: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.

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.

Outcome measures

Outcome measures
Measure
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Changes in the Insomnia Severity Index Score
Week 6
-0.38 score
Interval -1.91 to 1.15
-0.50 score
Interval -1.57 to 0.57
-0.12 score
Interval -1.71 to 1.48
-0.45 score
Interval -1.72 to 0.83
Changes in the Insomnia Severity Index Score
Week 12
-1.46 score
Interval -3.03 to 0.12
-0.84 score
Interval -1.95 to 0.28
-0.67 score
Interval -2.26 to 0.93
-1.26 score
Interval -2.56 to 0.05

Adverse Events

Routine Care Group

Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths

CAT Group

Serious events: 5 serious events
Other events: 15 other events
Deaths: 2 deaths

CAE Group

Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths

CAT + CAE Group

Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Routine Care Group
n=59 participants at risk
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
n=59 participants at risk
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
CAE Group
n=59 participants at risk
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 participants at risk
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Infections and infestations
Urinary tract infection
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Infections and infestations
COVID-19 infection
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Cardiac disorders
Patent foramen ovale-associated platypnea-orthodeoxia syndrome
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Endocrine disorders
Diabetes
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Nervous system disorders
Epilepsy
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Respiratory, thoracic and mediastinal disorders
Bronchitis
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Renal and urinary disorders
Hematuria
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
General disorders
Fall
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
3.4%
2/59 • from enrollment until end of follow-up, up to 12 weeks
Gastrointestinal disorders
Diarrhea
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
Investigations
Fatigue
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Infections and infestations
Influenza
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
Cardiac disorders
Heart failure
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
3.4%
2/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks

Other adverse events

Other adverse events
Measure
Routine Care Group
n=59 participants at risk
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
n=59 participants at risk
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
CAE Group
n=59 participants at risk
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
CAT + CAE Group
n=59 participants at risk
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Infections and infestations
Fever
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
5.1%
3/59 • from enrollment until end of follow-up, up to 12 weeks
General disorders
Hematoma around the site of needling
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
6.8%
4/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
8.5%
5/59 • from enrollment until end of follow-up, up to 12 weeks
Gastrointestinal disorders
Vomiting
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
5.1%
3/59 • from enrollment until end of follow-up, up to 12 weeks
General disorders
Bleeding at the site of needling
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
11.9%
7/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
6.8%
4/59 • from enrollment until end of follow-up, up to 12 weeks
General disorders
Fall
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
5.1%
3/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks

Additional Information

Zhang Zhangjin, Professor

School of Chinese Medicine, University of Hong Kong

Phone: 85239176445

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place