Alzheimer DiseaseNCT07222449
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
A study testing Photobiomodulation in people with Alzheimer Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 May 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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 psychological symptoms of dementia (BPSD)," such as agitation and sleep disturbances. Among these symptoms, nighttime sleep disorders and circadian rhythm disruptions not only deteriorate patients' quality of life but also impose substantial caregiving and medical costs on society, significantly increasing caregiver burden.
Currently, the assessment of such symptoms relies heavily on caregiver-reported questionnaires, which are often subjective and can only offer cross-sectional information. In Taiwan, this challenge is compounded by the fact that caregivers are often elderly individuals with cognitive decline themselves, making it difficult to accurately evaluate symptoms and develop effective treatment plans. Our previous research conducted in the UK revealed that even patients with late-stage dementia can accept to wear research-grade actigraphy with good compliance. Utilizing wearable devices for symptom assessment provides a more objective and continuous evaluation, with the analysis of emerging variables potentially contributing to a better understanding of dementia progression and the mechanisms underlying patients' circadian rhythm disturbances.
On the other hand, the treatment of circadian rhythm disruptions and sleep disorders in dementia patients heavily depends on medication. Many of these drugs lack proper indications for such use, and may increase the risk of falls and mortality. Near-infrared photobiomodulation (PBM) is a novel therapy emerged in recent years. Our team recently collaborated with Harvard University under a project funded by the Taiwanese National Science and Technology Council, successfully publishing the first findings on a "wearable PBM device" designed for home use in treating depression. The study demonstrated that the device might help improve sleep problems in elderly individuals with depression. If dementia patients can simultaneously use this device along with actigraphy devices, it could not only alleviate their sleep and circadian rhythm disturbances but also provide objective, continuous multi-dimensional symptom assessments through actigraphy and its build-in sensors.
This four-year project aims to begin with exploring "digital inclusivity," first validating the feasibility of using research-grade actigraphy among people living with Alzheimer's dementia in Taiwan, and establishing a research platform incorporating wearable devices data in this population. The investigators will then continue collaborating with Harvard University to conduct a double-blind randomized clinical trial, confirming the efficacy of wearable PBM devices in improving sleep, circadian rhythm disturbances, and other BPSD among these patients. Additionally, the investigators will assess the experiences of both patients and caregivers using a combined "digital therapy" approach involving both devices.
Finally, through the integration of the data across the four years from wearable devices, clinical symptom assessments, and the latest validated blood-based biomarkers for Alzheimer's disease, the investigators will conduct a longitudinal analysis. Collaborating with the largest European remote dementia care team, RADAR-AD, the investigators will explore potential digital phenotypes for dementia and examine the interactions between circadian rhythm disturbances, cognitive decline progression, and biomarkers. The ultimate goal is to establish a novel three-dimensional management model for dementia patients encompassing "clinical symptoms (cognitive and non-cognitive)," "lifestyle and functionality," and "biological markers."
- Conditions
- Alzheimer Disease
- Being tested
- Photobiomodulation, Sham (No Treatment)
- Keywords
- Alzheimer's disease, wearable device, behavioural and psychological symptoms of dementia (BPSD), blood-based biomarkersnear infrared photobiomodulation, sleep, circadian rhythm, blood-based biomarkers
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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 group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Participants allocated to this arm will receive photobiomodulation for up to 8 weeks, using a wearable headband. Receives: Device: Photobiomodulation |
| sham | Sham comparator | Participants allocated to this arm will not receive photobiomodulation for up to 8 weeks, using a sham wearable headband. Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start11 May 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, sham-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, King's College London
- Responsible party
- Principal investigator, Ta-wei Guu, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222449
- Sponsor's protocol ID
- 114WFD2410317
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We will decide if the IPD can be shared before the end of the study.
Publications
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.
PubMed 39706483Guu 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.
PubMed 38497216
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07222449
- Acronym / sponsor ID
- 114WFD2410317
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, King's College London
- Study start
- 11 May 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 psychological symptoms of dementia (BPSD)," such as agitation and sleep disturbances. Among these symptoms, nighttime sleep disorders and circadian rhythm disruptions not only deteriorate patients' quality of life but also impose substantial caregiving and medical costs on society, significantly increasing caregiver burden.
Currently, the assessment of such symptoms relies heavily on caregiver-reported questionnaires, which are often subjective and can only offer cross-sectional information. In Taiwan, this challenge is compounded by the fact that caregivers are often elderly individuals with cognitive decline themselves, making it difficult to accurately evaluate symptoms and develop effective treatment plans. Our previous research conducted in the UK revealed that even patients with late-stage dementia can accept to wear research-grade actigraphy with good compliance. Utilizing wearable devices for symptom assessment provides a more objective and continuous evaluation, with the analysis of emerging variables potentially contributing to a better understanding of dementia progression and the mechanisms underlying patients' circadian rhythm disturbances.
On the other hand, the treatment of circadian rhythm disruptions and sleep disorders in dementia patients heavily depends on medication. Many of these drugs lack proper indications for such use, and may increase the risk of falls and mortality. Near-infrared photobiomodulation (PBM) is a novel therapy emerged in recent years. Our team recently collaborated with Harvard University under a project funded by the Taiwanese National Science and Technology Council, successfully publishing the first findings on a "wearable PBM device" designed for home use in treating depression. The study demonstrated that the device might help improve sleep problems in elderly individuals with depression. If dementia patients can simultaneously use this device along with actigraphy devices, it could not only alleviate their sleep and circadian rhythm disturbances but also provide objective, continuous multi-dimensional symptom assessments through actigraphy and its build-in sensors.
This four-year project aims to begin with exploring "digital inclusivity," first validating the feasibility of using research-grade actigraphy among people living with Alzheimer's dementia in Taiwan, and establishing a research platform incorporating wearable devices data in this population. The investigators will then continue collaborating with Harvard University to conduct a double-blind randomized clinical trial, confirming the efficacy of wearable PBM devices in improving sleep, circadian rhythm disturbances, and other BPSD among these patients. Additionally, the investigators will assess the experiences of both patients and caregivers using a combined "digital therapy" approach involving both devices.
Finally, through the integration of the data across the four years from wearable devices, clinical symptom assessments, and the latest validated blood-based biomarkers for Alzheimer's disease, the investigators will conduct a longitudinal analysis. Collaborating with the largest European remote dementia care team, RADAR-AD, the investigators will explore potential digital phenotypes for dementia and examine the interactions between circadian rhythm disturbances, cognitive decline progression, and biomarkers. The ultimate goal is to establish a novel three-dimensional management model for dementia patients encompassing "clinical symptoms (cognitive and non-cognitive)," "lifestyle and functionality," and "biological markers."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: PhotobiomodulationParticipants allocated to this arm will receive photobiomodulation for up to 8 weeks, using a wearable headband. |
| sham | Sham comparator | Device: Sham (No Treatment)Participants allocated to this arm will not receive photobiomodulation for up to 8 weeks, using a sham wearable headband. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationA near-infrared photobiomodulation wearable device. | Device | Photobiomodulation |
| Sham (No Treatment)Participants allocated to this arm will receive neglectable photobiomodulation for up to 8 weeks, using a sham wearable headband. | Device | sham |
Primary outcome
Sleep
Time frame: 8 weeks post-treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 39706483Guu 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.
- Results publication: PubMed 38497216Guu 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.
- Individual participant dataSharing planned: Undecided. We will decide if the IPD can be shared before the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Alzheimer Disease, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: 8 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07222449, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.