Status:
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
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
Massachusetts General Hospital
King's College London
Conditions:
Alzheimer Disease
Eligibility:
All Genders
Phase:
NA
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 psychol...
Detailed Description
In 2025, Taiwan will become a super-aged society, with a continuous rise in the number of people living with Alzheimer's dementia. The majority of these patients will experience "behavioural and psych...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT07222449
Start Date
December 1 2025
End Date
July 31 2029
Last Update
October 29 2025
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