This is an assessor-blinded, randomized controlled trial. A total of 188 older adults aged 60-85 years with early/mild AD will be recruited from care and attention homes for the elderly and elderly activity centers. Participants will be randomly assigned to receive least acupressure control (LAC, n = 94) and Comfy Acupressure for the Elderly (CAE, n = 94), administered by caregivers (i.e., trained research assistants), for 3 sessions a week for 12 months. The primary outcome is the change in the Montreal Cognitive Assessment (MoCA) score from baseline. The secondary outcomes include functional independence, psychological well-being, sleep quality, and health-related quality of life. The outcomes will be assessed at baseline and once bimonthly thereafter, totaling 7 sessions. A linear mixed-effect model will be applied to compare the primary and secondary outcomes. Three blood samples will be collected at baseline, 6 months, and 12 months, respectively, and the baseline blood sample will be immediately measured for the measurement of plasma Aβ42, Aβ40, p-tau181, and p-tau217, blood glial fibrillary acidic protein (GFAP) and neurofilament light chain protein (NfL). Repeated two-way variance (ANOVA) will be used to detect significant differences in blood biomarkers between the two groups. Linear regression will be conducted to examine inter-correlations between clinical outcomes and biomarker levels. Health and social care resource use will additionally be recorded at baseline, 6 months, and 12 months for the economic evaluation to examine the cost-effectiveness of the CAE intervention compared with LAC.
have at least one of the following abnormal plasma amyloid and tau levels: Aβ42/Aβ40 ratio ≤ 0.17, p-tau217 > 0.15 pg/ml, or/and p-tau181 > 3.3 pg/ml
have mild neurocognitive disorder with the Montreal Cognitive Assessment, Hong Kong version (HK-MoCA) in classifying mild neurocognitive disorder, in which mild neurocognitive disorder is defined as those whose HK-MoCA score falls between the 16th and 2nd percentile of his/her peers adjusted for age and education
show moderate-to-severe dementia, as evidenced by a HK-MoCA score falling below the 2nd percentile of his/her peers adjusted for age and education
cannot proficiently communicate due to language function impairment
have severe skin lesions on acupressure areas
had a surgery on the head or neck
Parallel
Comfy Acupressure for the Elderly
Procedure/SurgeryCAE consists of 12 steps, which need about 15 minutes to complete and concentrate on the acupoints on the face, head, neck, shoulder, and hand. CAE intervention will be conducted 3 times per week for 12 consecutive months by trained research assistants.
Least acupressure control
Procedure/SurgeryLAC consists of three acupoints in the head, neck/shoulder, and hand: Tongtian (BL7), Jianzhen (SI9), and Shousanli (LI10). The completion of one LAC session needs about 3 to 4 minutes. LAC intervention will be conducted 3 times per week for 12 consecutive months by trained research assistants.
Change in the Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is used to measure cognitive function , which contains visuospatial, language, concentration, working memory, memory recall, and orientation domains. Its overall score ranges from 0 to 30. A higher score indicates a better cognitive function.
Change in the Digit Span Forward
The Digit Span Forward (DSF) is used to measure short-term auditory-verbal memory and attention and its overall score ranges from 0 to 14. A higher score indicates a better function.
Change in the Digit Span Reverse
The Digit Span Reverse (DSR) is used to measure Digit Span Forward (DSF) is used to measure working memory, cognitive control, and executive function and its overall score ranges from 0 to 14. A higher score indicates a better function.
Change in the Quality of Life in Alzheimer's Disease
The Quality of Life in Alzheimer's Disease (QOL-AD) is used to measure quality of life, rated by both self and caregivers to measure physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. Its overall score ranges from 13 to 52. A higher score indicates a better quality of life.
Change in the 5-level EQ-5D version
The 5-level EQ-5D version (EQ-5D-5L) is used to measure health-related quality of life. It comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels (1 = no problems, 5 = extreme problems/unable to do), together with a visual analogue scale (EQ VAS) on which respondents rate their health today from 0 (the worst health you can imagine) to 100 (the best health you can imagine). A lower score in the five dimensions indicates a better quality of life, while a higher score in the EQ VAS indicates a better health.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: