Wearables-and Blood-based Biomarkers-incorporated Modernisation of Circadian Rhythm Disruption Management in People Living With Alzheimer's Dementia: A Stepwise Study From Digital Inclusivity, Digital Therapy, to Digital Phenotyping and Biomarker Exploration

Sponsor
China Medical University Hospital
Study ID
NCT07222449
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Photobiomodulation — DEVICE
    A near-infrared photobiomodulation wearable device.
  • Sham (No Treatment) — DEVICE
    Participants allocated to this arm will receive neglectable photobiomodulation for up to 8 weeks, using a sham wearable headband.

Study Details

By 2025, Taiwan will become a super-aged society, with the number of Alzheimer's disease patients continuing to rise. However, the vast majority of dementia patients experience "behavioral and psychological symptoms of dementia" (BPSD), such as circadian rhythm disruptions and sleep disorders, which are not only difficult to assess accurately but also lack safe and effective treatments. If "wearable devices" can be accepted by elderly dementia patients, they may bring groundbreaking changes to both assessment and treatment approaches. This project builds upon previous research and outcomes funded by the National Science and Technology Council (NSTC), the Ministry of Education, and the UK Alzheimer's Research UK (ARUK). Over four years, the project will begin by exploring "digital inclusivity" to validate the feasibility of research-grade actigraphy devices for dementia patients in Taiwan and establish a prototype research platform for wearable devices for these patients. Subsequently, in collaboration with Harvard University, the project will conduct a double-blind, randomized clinical trial to evaluate the efficacy of wearable photobiomodulation (PBM) devices in improving sleep, circadian rhythm disturbances, and other BPSD, as well as assess the user experience of integrating these two devices into a "digital therapy" model for both patients and caregivers. Finally, the project will integrate wearable device data, patient clinical symptoms, and longitudinal results from four years of tracking the latest Alzheimer's blood-based biomarkers. In collaboration with Europe's largest remote dementia care team, RADAR-AD, the project will analyze potential digital phenotypes of dementia, explore the interactions among circadian rhythm disturbances, cognitive decline rates, and biomarkers, and establish a three-dimensional assessment model for dementia patients encompassing "clinical symptoms (both cognitive and non-cognitive)," "lifestyle and functionality," and "biological markers." This innovative approach aims to provide a more comprehensive understanding and treatment of dementia.

Key Dates

First listed
Oct 29, 2025
Start date
May 11, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Photobiomodulation
    Participants allocated to this arm will receive photobiomodulation for up to 8 weeks, using a wearable headband.
  • Sham Comparator: sham
    Participants allocated to this arm will not receive photobiomodulation for up to 8 weeks, using a sham wearable headband.

Primary Outcome Measure

Sleep [ Time Frame: 8 weeks post-treatment ]

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