NCT07222449 · NOT YET RECRUITING
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
This trial is testing whether a wearable light therapy device called photobiomodulation can improve sleep and disrupted daily rhythms in people already living with Alzheimer's dementia. Researchers will also track blood biomarkers and wearable sensor data over four years. This is a Phase NA study — meaning it is classified as a non-pharmacological intervention trial, with the randomized portion comparing the device against a sham version to test whether it actually works.
Eligibility criteria
Inclusion Criteria: * 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). Exclusion Criteria: 1. Severe cataracts significantly impairing visual light sensitivity. 2. Physical conditions (e.g., wrist disability) that prevent the wearing of a wrist actigraph. 3. Intracranial lesions or surgeries that have permanently disrupted circadian rhythm regulation systems (e.g., suprachiasmatic nucleus or pineal gland tumors). 4. Any other conditions deemed unsuitable for participation by the clinical physician, such as: * Currently experiencing acute delirium. * Suffering from respiratory infections, including COVID-19. 5. 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-11