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

NCT07779863 | Not Yet Recruiting

• 2 other identifiers: UW 25-56423244461
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Acupressure; Dementia; Amyloid and tau biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12

Secondary Outcomes (12)

• Change in the Digit Span Forward

  Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12

• Change in the Digit Span Reverse

  Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12

• Change in the Quality of Life in Alzheimer's Disease

  Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12

• Change in the 5-level EQ-5D version

  Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12

• Change in the Modified Barthel Index

  Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12

Study Arms (2)

Comfy Acupressure for the Elderly (CAE)

EXPERIMENTAL

Procedure: Comfy Acupressure for the Elderly

Least acupressure control (LAC)

SHAM COMPARATOR

Procedure: Least acupressure control

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.

Also known as: CAE

Comfy Acupressure for the Elderly (CAE)

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.

Also known as: LAC

Least acupressure control (LAC)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• have a medical condition that is a contraindication for acupressure.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Chinese Medicine, University of Hong Kong

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhang-Jin Zhang, PhD

CONTACT

(852) 39176445; zhangzj@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: The IPD will not be openly available due to reasons of participants' privacy and will be available from the principal investigator upon reasonable request.

Locations

HK (1)