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Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07779863). This is a study registration, not published results. Lead sponsor: The University of Hong Kong. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 188 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: PROCEDURE: Comfy Acupressure for the Elderly; PROCEDURE: Least acupressure control. Primary outcome measures: Change in the Montreal Cognitive Assessment, Hong Kong version , Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12. Brief summary: This is an assessor-blinded, randomized controlled trial. A total of 188 older adults aged 60-85 years with early/mild Alzheimer's disease (AD) will be recruited from care and attention homes for the elderly and elderly activity centres. They 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, Hong Kong version (HK-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, totalling 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). Two-way repeated measures analysis of 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.