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

NCT07222449 | Not Yet Recruiting FDA Device

• 1 other identifier: 114WFD2410317
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; wearable device; behavioural and psychological symptoms of dementia (BPSD); blood-based biomarkersnear infrared photobiomodulation; sleep; circadian rhythm; blood-based biomarkers

Outcome Measures

Primary Outcomes (1)

• Sleep

  As measured by Pittsburgh Sleep Quality Index (PSQI), a questionnaire providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

  8 weeks post-treatment

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

Participants allocated to this arm will receive photobiomodulation for up to 8 weeks, using a wearable headband.

Device: Photobiomodulation

sham

SHAM COMPARATOR

Participants allocated to this arm will not receive photobiomodulation for up to 8 weeks, using a sham wearable headband.

Device: Sham (No Treatment)

Interventions

Photobiomodulation DEVICE

A near-infrared photobiomodulation wearable device.

Photobiomodulation

Sham (No Treatment) DEVICE

Participants allocated to this arm will receive neglectable photobiomodulation for up to 8 weeks, using a sham wearable headband.

sham

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Massachusetts General Hospital: collaborator
• King's College London: collaborator

Related Publications (2)

• Guu TW, Cassano P, Li WJ, Tseng YH, Ho WY, Lin YT, Lin SY, Chang JP, Mischoulon D, Su KP. Wearable, self-administered transcranial photobiomodulation for major depressive disorder and sleep: A randomized, double blind, sham-controlled trial. J Affect Disord. 2025 Mar 1;372:635-642. doi: 10.1016/j.jad.2024.12.065. Epub 2024 Dec 18.

  PMID: 39706483 RESULT

• Guu TW, Brem AK, Albertyn CP, Kandangwa P, Aarsland D, Ffytche D. Wrist-worn actigraphy in agitated late-stage dementia patients: A feasibility study on digital inclusion. Alzheimers Dement. 2024 May;20(5):3211-3218. doi: 10.1002/alz.13772. Epub 2024 Mar 18.

  PMID: 38497216 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD

CONTACT

057837901; 066753@tool.caaumed.org.tw

Yueh-Heng Chiang, RN, MS.

CONTACT

isyuehheng@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Psychiatrist

Model Details: Randomised, sham-controlled trial

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: October 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02