Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease

Sponsor
The University of Hong Kong
Study ID
NCT07779863
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Comfy Acupressure for the Elderly — PROCEDURE
    CAE 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
    LAC 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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Comfy Acupressure for the Elderly (CAE)
  • Sham Comparator: Least acupressure control (LAC)

Primary Outcome Measure

Change in the Montreal Cognitive Assessment [ Time Frame: Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12 ]

Central Contacts

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