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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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 facts

Study ID: NCT07222449
Run by: China Medical University Hospital
People needed: 162
Starts: 2026-05-11
Expected to finish: 2029-07-31
Last updated by the study team: 2026-06-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet the diagnostic criteria for Possible Alzheimer's Disease (Possible AD) or Probable Alzheimer's Disease (Probable AD) as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA)
Have sleep disorders, assessed either by: (1) A Pittsburgh Sleep Quality Index (PSQI) total score of greater than five, or (2) A nighttime symptom severity-frequency product score of greater than four on the Neuropsychiatric Inventory as evaluated by caregivers.
Subjects must be community-based dementia patients who attend psychiatric outpatient clinics or participate in activities at dementia care centers or day care centers.
Prior to inclusion, informed consent must be obtained. If cognitive impairment prevents subjects from signing, consent may be obtained from their primary caregiver (who may be a legal or professional representative).

You may not qualify if…

Severe cataracts significantly impairing visual light sensitivity.
Physical conditions (e.g., wrist disability) that prevent the wearing of a wrist actigraph.
Intracranial lesions or surgeries that have permanently disrupted circadian rhythm regulation systems (e.g., suprachiasmatic nucleus or pineal gland tumors).
Any other conditions deemed unsuitable for participation by the clinical physician, such as:
Currently experiencing acute delirium.
Suffering from respiratory infections, including COVID-19.
For Phase II participants, individuals with significant skin conditions on the head or conditions that could affect the efficacy of light therapy will be excluded. These include cases with:
Hemangiomas.
Scleroderma.
Psoriasis.
Rashes.
Open wounds.
Tattoos on the head. Additionally, individuals with head implants or those who have undergone photosensitizing drug treatments within two weeks prior to trial participation will also be excluded.

Where it is running

China Medical University Beigang Hospital — Beigang, Yunlin, Taiwan

Full record on ClinicalTrials.gov

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