DementiaNCT07672171
Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia
A study testing Yin Fu Rui De Far-Infrared Radiator in people with Dementia and Alzheimer Disease, run by Juin-Hong Cherng at 1 site in Taiwan.
Trial summary
Alzheimer's disease (AD), the most common cause of dementia, is a progressive neurodegenerative disorder characterized by cognitive decline, including impaired learning ability, memory loss, and behavioral disturbances. Read more about this study
- Who is it for?
- Ages 61 to 92 years
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Yin Fu Rui De Far-Infrared Radiator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2022to 31 Oct 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 61 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Alzheimer's disease dementia.
- Mini-Mental State Examination (MMSE) score between 18 and 24 (inclusive).
- Currently prescribed and maintained on a stable regimen of anti-dementia medication.
- No sensory deficits or impairment regarding skin temperature perception.
- Patient or a Legally Authorized Representative (LAR) must be willing and capable of providing written informed consent prior to enrollment.
Who cannot join
- Non-Alzheimer's disease dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia).
- Known hypersensitivity to heat or light, including the current use of photosensitizing medications.
- Diminished thermal or heat sensitivity, such as from the concurrent use of analgesics, sedatives, or consumption of alcoholic beverages.
- Acute injury or acute localized inflammation, including active inflammation, infection, or ulcerated wounds.
- Concomitant acute venous thrombosis, varicose veins, severe peripheral arterial occlusive disease (Stage III or IV), lymphatic disease, acute rheumatoid arthritis, acute gout, or active fever.
- Presence of mottled erythema or other abnormal dermatological conditions on the scalp or neck.
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- Localized skin lesions, damage, or open wounds at the device contact sites.
- Concurrent participation in any other clinical trial.
- Any other underlying pathological conditions or clinical statuses that, based on medical consensus, would preclude safe participation in the study.
- Failure or refusal to provide signed informed consent.
- Inability or unwillingness to comply with the trial protocols, schedules, or required follow-up evaluations.
- History or presence of hemorrhagic disorders or bleeding-related diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Trial-Service General Hospital, National Defense Medical University
Taipei, 11490
Juin-Hong Cherng, Ph.D., 886-2-87923100 ext. 18699, 18681, i72bbb@gmail.com
Gang-Yi Fan, Ph.D., 886-2-87923100 ext. 18699, u9310318@gmail.com
About this study
Official title: To Explore the Effect of Far Infrared Therapy on Cognitive Function of Patients With Dementia
Alzheimer's disease (AD), the most common cause of dementia, is a progressive neurodegenerative disorder characterized by cognitive decline, including impaired learning ability, memory loss, and behavioral disturbances.
According to surveys conducted by the Ministry of Health and Welfare in Taiwan, the prevalence of dementia among individuals aged 65 years and older was estimated at 7.86% in 2018, affecting more than 280,000 individuals, and is projected to approach 900,000 by 2065, resulting in substantial medical, social, and economic burdens. Current pharmacological treatments provide only limited symptomatic benefits and may be associated with adverse effects. Therefore, safe and effective non-pharmacological interventions that may support cognitive function and reduce caregiver burden are urgently needed.
Read more
Experimental studies suggest that far-infrared (FIR) irradiation may enhance mitochondrial oxidative phosphorylation, increase ATP production, and promote microglial amyloid-β clearance, which may help delay the progression of Alzheimer's disease.
This trial aims to investigate the safety and effects of far-infrared (FIR) therapy on cognitive function in patients with Alzheimer's disease.
The findings may support the clinical application of FIR therapy as a non-pharmacological intervention to improve cognitive function and quality of life, reduce medication burden and treatment-related side effects, lessen caregiver burden, delay institutionalization, and reduce the social and economic burden associated with Alzheimer's disease.
Read the detailed description
Alzheimer's disease (AD), the most common cause of dementia, is a progressive neurodegenerative disorder characterized by cognitive decline, memory impairment, behavioral disturbances, and deterioration in activities of daily living. According to surveys conducted by the Ministry of Health and Welfare in Taiwan, the prevalence of dementia among individuals aged 65 years and older was estimated at 7.86% in 2018, affecting more than 280,000 individuals, and is projected to approach 900,000 by 2065. As the disease progresses, increasing cognitive impairment places substantial medical, social, and economic burdens on patients, caregivers, and healthcare systems. Current pharmacological treatments for Alzheimer's disease provide limited symptomatic benefits and may be associated with adverse effects. Therefore, alternative non-pharmacological interventions that may support cognitive function and improve quality of life are being actively explored.
Experimental studies have suggested that far-infrared (FIR) irradiation may exert beneficial biological effects on mitochondrial function and neuroinflammation. FIR exposure has been reported to enhance mitochondrial oxidative phosphorylation, increase adenosine triphosphate (ATP) production, and improve microglial activity involved in amyloid-β (Aβ) clearance. These mechanisms may potentially delay neurodegeneration associated with Alzheimer's disease progression.
This clinical study is designed as a single-center, randomized, single-blind, parallel-group controlled trial conducted in Taiwan. A total of up to 40 participants with Alzheimer's disease will be enrolled and randomly assigned in a 1:1 ratio to either the active FIR treatment group or the sham-control group. The investigational device is the Yin FuRui De Far-Infrared Therapy Device (Model CE-1889), which generates far-infrared wavelengths ranging from 4 to 14 μm.
Participants in the treatment group will receive daily FIR irradiation therapy using a head-mounted FIR device. FIR irradiation will be applied once daily to the Fengfu (GV16) and Baihui (GV20) acupoints for 30 minutes per site. Participants in the control group will use an identical device with the FIR function disabled. Prior to home use, study personnel will provide device-use training and instructions to participants and their caregivers.
The primary objective of the study is to evaluate the safety of the FIR therapy device. Safety assessments will include monitoring the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) associated with the investigational device throughout the study period.
Secondary objectives include evaluating changes in cognitive performance using the Mini-Mental State Examination (MMSE) and assessing mitochondrial function biomarkers obtained from peripheral blood samples. Outcome assessments will be conducted at baseline, Month 1, Month 3, and Month 12.
Safety analyses will be conducted in the Intent-to-Treat (ITT) population. Baseline normal and post-treatment abnormal cases, as well as their proportions, will be summarized separately for the intervention and control groups. The number and incidence rate of adverse events (AEs) and serious adverse events (SAEs) will be calculated and descriptively analyzed. Group comparisons of adverse event incidence will be performed using the Chi-Squared test. Efficacy analyses for MMSE scores and mitochondrial function biomarkers will include paired-sample t tests and independent-sample t tests, as appropriate.
This study aims to determine whether the head-mounted FIR therapy may serve as a safe adjunctive non-pharmacological intervention for patients with Alzheimer's disease to support cognitive function, improve quality of life, reduce caregiver burden, and potentially delay disease progression and institutional care.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Yin Fu Rui De Far-Infrared Radiator, Sham Far-Infrared Radiator
- Keywords
- Far-infrared therapy, Dementia, Alzheimer disease
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yin Fu Rui De Far-Infrared RadiatorDevice
Also called Yin Fu Rui De Far-Infrared Radiator (Model CE-1899)
The investigational device is a head-mounted far-infrared therapy device manufactured in Taiwan.
- Emission wavelength: 4-14 μm
- Heating mechanism: ceramic semiconductor heating element
- Design: head-mounted structure with external housing to reduce energy dissipation
- Application sites: Fengfu (GV16) and Baihui (GV20)
Regulatory status:
Approved medical device (Medical Device License No. 006083 issued by the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan).
Approved indications include relief of fatigue, improvement of local blood circulation, and reduction of muscle stiffness and neuralgia.
In this study, the device is used investigationally to evaluate potential effects on cognitive function in patients with Alzheimer's disease dementia.
Sham Far-Infrared RadiatorDevice
Also called Sham Far-Infrared Device (Model CE-1889)
The sham device is identical in appearance to the active device but without active far-infrared emission.
It is used to maintain participant blinding and control for non-specific effects in device-based interventions.
| Study group | Role | What they receive |
|---|---|---|
| Active Far-Infrared (FIR) Therapy | Experimental | Participants will receive active far-infrared (FIR) therapy using a head-mounted FIR device (Yin Fu Rui De Far-Infrared Therapy Device, Model CE-1889).
The device delivers far-infrared irradiation (4-14 μm) and is applied to Fengfu (GV16) and Baihui (GV20) acupoints for 30 minutes per site, once daily for 12 months.
The intervention will be initiated under supervised training at the study site, followed by home-based self-administration by participants and/or caregivers. Participants will continue their usual medical care without changes to standard pharmacological treatment. Receives: Device: Yin Fu Rui De Far-Infrared Radiator |
| Sham Control | Sham comparator | Participants will receive a sham intervention using an identical-appearing head-mounted device (Yin FuRui De Far-Infrared Therapy Device, Model CE-1889) with the far-infrared emission function disabled.
The sham device will be applied to the same acupoints (Fengfu GV16 and Baihui GV20) for 30 minutes per site, once daily for 12 months.
Procedures, duration, and application schedule will be identical to the active treatment group to ensure blinding. The sham device does not emit far-infrared radiation. Receives: Device: Sham Far-Infrared Radiator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Adverse Events (AEs)
Safety will be evaluated by tracking any unfavorable clinical occurrence associated with the use of the Yin Fu Rui De far-infrared therapy device, assessed through regular clinical physical examinations and documented via Case Report Forms (CRFs). The unit of measure is the number of participants experiencing at least one AE. Safety analysis will be performed using the Intent-to-Treat (ITT) population (N=40). Following the protocol's statistical plan, the specific clinical manifestations, severity, and device-causality of all AEs will be documented. The proportions of pre-treatment normal versus post-treatment abnormal cases, along with AE incidence rates, will be calculated and compared between the intervention and control groups using the Chi-Squared Test.
Unit of Measure: Number of participants
Measured: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Serious Adverse Events (SAEs)
Safety will be evaluated by focusing on serious safety concerns associated with the use of the Yin Fu Rui De far-infrared therapy device, assessed through clinical evaluations and documented via Case Report Forms (CRFs). Serious adverse events (SAEs) are defined as events resulting in death, life-threatening conditions, prolonged hospitalization, or permanent disability. Safety analysis will be performed using the Intent-to-Treat (ITT) population (N=40). The relationship between the device and SAEs will be documented, and the proportions of pre-treatment normal versus post-treatment abnormal cases, alongside SAE incidence rates, will be statistically compared between the intervention and control groups using the Chi-Squared Test.
Measured: Time Frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
Secondary outcomes (2)
Change From Baseline in Cognitive Function Score Assessed by MMSE
Assessment of cognitive improvement or decline using the Mini-Mental State Examination (MMSE), a standardized 30-point questionnaire. Following the protocol's statistical plan, within-group changes from baseline will be analyzed using paired-sample t-tests, and differences in changes between the intervention and control groups will be compared using independent-sample t-tests.
Unit of Measure: Score on the MMSE scale (Range: 0 to 30, where higher scores indicate better cognitive function)
Measured: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
Change From Baseline in Mitochondrial Adenosine Triphosphate (ATP) Production Rate
Evaluation of mitochondrial energetic pathways and cellular respiration efficiency through peripheral blood biomarker analysis. This test involves collecting blood samples (totaling less than 20 mL) to measure the quantitative rate of mitochondrial ATP production using a standardized fluorometric assay. Following the protocol's statistical plan, within-group changes from baseline will be analyzed using paired-sample t-tests, and differences between the intervention and control groups will be evaluated using independent-sample t-tests.
Unit of Measure: picomoles per minute per milligram of protein (pmol/min/mg)
Measured: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Oct 2022
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- This is a single-center, randomized, single-blind, sham-controlled, parallel-group interventional study. Eligible participants diagnosed with Alzheimer's disease will be randomly assigned in a 1:1 ratio to either the active far-infrared (FIR) treatment group or the sham-control group. Both groups will undergo their respective home-based interventions simultaneously over a continuous 12-month period without crossover or group reassignment. The study is designed to compare the safety and efficacy of active FIR therapy versus sham control on cognitive function and mitochondrial function in patients with Alzheimer's disease.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juin-Hong Cherng
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor-investigator, Juin-Hong Cherng, National Defense Medical Center, Taiwan
- Investigators
- Jiunn-Tay Lee, Ｍ.D., Principal investigator, Trial-Service General Hospital, National Defense Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672171
- Sponsor's protocol ID
- YIN FU RUI DE 2026
- Status last verified
- May 2026
- First submitted
- 3 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy and confidentiality of the participants in accordance with personal data protection regulations, individual participant data (IPD) will not be publicly shared. The clinical study results will be disseminated exclusively through aggregated data in peer-reviewed scientific publications and official trial registries.
Publications
Leong, K.-I., Chen, Y.-C., & Chen, J.-H. (2014). Dementia: A focused review. Journal of Internal Medicine of Taiwan, 25(3), 151-157. https://www.mohw.gov.tw/dl-77702-2060aef3-99b0-48b0-97ff-53d1210b6acf.html
Chen H, Chen F, Jiang Y, Zhang L, Hu G, Sun F, Zhang M, Ji Y, Chen Y, Che G, Zhou X, Zhang Y. A Review of ApoE4 Interference Targeting Mitophagy Molecular Pathways for Alzheimer's Disease. Front Aging Neurosci. 2022 May 20;14:881239. doi: 10.3389/fnagi.2022.881239. eCollection 2022.
PubMed 35669462Hsieh, Y.-Y., Lin, J.-P., Liu, W.-C., & Lin, C.-C. (2007). Medical applications and the action mechanisms of far-infrared ray. Taiwan Journal of Applied Radiation and Isotopes, 3(3), 333-340. https://doi.org/10.29832/TJARI.200709.0002
Department of Statistics, Ministry of Health and Welfare (September 18, 2020). World Alzheimer's Day Health and Welfare Statistics Bulletin, Department of Statistics, Ministry of Health and Welfare. https://dep.mohw.gov.tw/DOS/cp-5112-63351-113.html
Vatansever F, Hamblin MR. Far infrared radiation (FIR): its biological effects and medical applications. Photonics Lasers Med. 2012 Nov 1;4:255-266. doi: 10.1515/plm-2012-0034.
PubMed 23833705Li Q, Peng J, Luo Y, Zhou J, Li T, Cao L, Peng S, Zuo Z, Wang Z. Far infrared light irradiation enhances Abeta clearance via increased exocytotic microglial ATP and ameliorates cognitive deficit in Alzheimer's disease-like mice. J Neuroinflammation. 2022 Jun 14;19(1):145. doi: 10.1186/s12974-022-02521-y.
PubMed 35701825Huang PH, Chen JW, Lin CP, Chen YH, Wang CH, Leu HB, Lin SJ. Far infra-red therapy promotes ischemia-induced angiogenesis in diabetic mice and restores high glucose-suppressed endothelial progenitor cell functions. Cardiovasc Diabetol. 2012 Aug 15;11:99. doi: 10.1186/1475-2840-11-99.
PubMed 22894755Fukui K, Kimura S, Kato Y, Kohno M. Effects of far infrared light on Alzheimer's disease-transgenic mice. PLoS One. 2021 Jun 17;16(6):e0253320. doi: 10.1371/journal.pone.0253320. eCollection 2021.
PubMed 34138944Fairley LH, Wong JH, Barron AM. Mitochondrial Regulation of Microglial Immunometabolism in Alzheimer's Disease. Front Immunol. 2021 Feb 25;12:624538. doi: 10.3389/fimmu.2021.624538. eCollection 2021.
PubMed 33717134Chen TY, Yang YC, Sha YN, Chou JR, Liu BS. Far-Infrared Therapy Promotes Nerve Repair following End-to-End Neurorrhaphy in Rat Models of Sciatic Nerve Injury. Evid Based Complement Alternat Med. 2015;2015:207245. doi: 10.1155/2015/207245. Epub 2015 Feb 3.
PubMed 25722734
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effect of Far Infrared Therapy on Cognitive Function of Patients With Dementia
- ClinicalTrials.gov ID
- NCT07672171
- Acronym / sponsor ID
- YIN FU RUI DE 2026
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Far-infrared therapy, Dementia, Alzheimer disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Juin-Hong CherngUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 26 Jun 2026 (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.
Alzheimer's disease (AD), the most common cause of dementia, is a progressive neurodegenerative disorder characterized by cognitive decline, including impaired learning ability, memory loss, and behavioral disturbances.
According to surveys conducted by the Ministry of Health and Welfare in Taiwan, the prevalence of dementia among individuals aged 65 years and older was estimated at 7.86% in 2018, affecting more than 280,000 individuals, and is projected to approach 900,000 by 2065, resulting in substantial medical, social, and economic burdens. Current pharmacological treatments provide only limited symptomatic benefits and may be associated with adverse effects. Therefore, safe and effective non-pharmacological interventions that may support cognitive function and reduce caregiver burden are urgently needed.
Experimental studies suggest that far-infrared (FIR) irradiation may enhance mitochondrial oxidative phosphorylation, increase ATP production, and promote microglial amyloid-β clearance, which may help delay the progression of Alzheimer's disease.
This trial aims to investigate the safety and effects of far-infrared (FIR) therapy on cognitive function in patients with Alzheimer's disease.
The findings may support the clinical application of FIR therapy as a non-pharmacological intervention to improve cognitive function and quality of life, reduce medication burden and treatment-related side effects, lessen caregiver burden, delay institutionalization, and reduce the social and economic burden associated with Alzheimer's disease.
Detailed description
Alzheimer's disease (AD), the most common cause of dementia, is a progressive neurodegenerative disorder characterized by cognitive decline, memory impairment, behavioral disturbances, and deterioration in activities of daily living. According to surveys conducted by the Ministry of Health and Welfare in Taiwan, the prevalence of dementia among individuals aged 65 years and older was estimated at 7.86% in 2018, affecting more than 280,000 individuals, and is projected to approach 900,000 by 2065. As the disease progresses, increasing cognitive impairment places substantial medical, social, and economic burdens on patients, caregivers, and healthcare systems. Current pharmacological treatments for Alzheimer's disease provide limited symptomatic benefits and may be associated with adverse effects. Therefore, alternative non-pharmacological interventions that may support cognitive function and improve quality of life are being actively explored.
Experimental studies have suggested that far-infrared (FIR) irradiation may exert beneficial biological effects on mitochondrial function and neuroinflammation. FIR exposure has been reported to enhance mitochondrial oxidative phosphorylation, increase adenosine triphosphate (ATP) production, and improve microglial activity involved in amyloid-β (Aβ) clearance. These mechanisms may potentially delay neurodegeneration associated with Alzheimer's disease progression.
This clinical study is designed as a single-center, randomized, single-blind, parallel-group controlled trial conducted in Taiwan. A total of up to 40 participants with Alzheimer's disease will be enrolled and randomly assigned in a 1:1 ratio to either the active FIR treatment group or the sham-control group. The investigational device is the Yin FuRui De Far-Infrared Therapy Device (Model CE-1889), which generates far-infrared wavelengths ranging from 4 to 14 μm.
Participants in the treatment group will receive daily FIR irradiation therapy using a head-mounted FIR device. FIR irradiation will be applied once daily to the Fengfu (GV16) and Baihui (GV20) acupoints for 30 minutes per site. Participants in the control group will use an identical device with the FIR function disabled. Prior to home use, study personnel will provide device-use training and instructions to participants and their caregivers.
The primary objective of the study is to evaluate the safety of the FIR therapy device. Safety assessments will include monitoring the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) associated with the investigational device throughout the study period.
Secondary objectives include evaluating changes in cognitive performance using the Mini-Mental State Examination (MMSE) and assessing mitochondrial function biomarkers obtained from peripheral blood samples. Outcome assessments will be conducted at baseline, Month 1, Month 3, and Month 12.
Safety analyses will be conducted in the Intent-to-Treat (ITT) population. Baseline normal and post-treatment abnormal cases, as well as their proportions, will be summarized separately for the intervention and control groups. The number and incidence rate of adverse events (AEs) and serious adverse events (SAEs) will be calculated and descriptively analyzed. Group comparisons of adverse event incidence will be performed using the Chi-Squared test. Efficacy analyses for MMSE scores and mitochondrial function biomarkers will include paired-sample t tests and independent-sample t tests, as appropriate.
This study aims to determine whether the head-mounted FIR therapy may serve as a safe adjunctive non-pharmacological intervention for patients with Alzheimer's disease to support cognitive function, improve quality of life, reduce caregiver burden, and potentially delay disease progression and institutional care.
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
- This is a single-center, randomized, single-blind, sham-controlled, parallel-group interventional study. Eligible participants diagnosed with Alzheimer's disease will be randomly assigned in a 1:1 ratio to either the active far-infrared (FIR) treatment group or the sham-control group. Both groups will undergo their respective home-based interventions simultaneously over a continuous 12-month period without crossover or group reassignment. The study is designed to compare the safety and efficacy of active FIR therapy versus sham control on cognitive function and mitochondrial function in patients with Alzheimer's disease.
| Arm | Type | Receives |
|---|---|---|
| Active Far-Infrared (FIR) Therapy | Experimental | Device: Yin Fu Rui De Far-Infrared RadiatorParticipants will receive active far-infrared (FIR) therapy using a head-mounted FIR device (Yin Fu Rui De Far-Infrared Therapy Device, Model CE-1889). The device delivers far-infrared irradiation (4-14 μm) and is applied to Fengfu (GV16) and Baihui (GV20) acupoints for 30 minutes per site, once daily for 12 months. The intervention will be initiated under supervised training at the study site, followed by home-based self-administration by participants and/or caregivers. Participants will continue their usual medical care without changes to standard pharmacological treatment. |
| Sham Control | Sham comparator | Device: Sham Far-Infrared RadiatorParticipants will receive a sham intervention using an identical-appearing head-mounted device (Yin FuRui De Far-Infrared Therapy Device, Model CE-1889) with the far-infrared emission function disabled. The sham device will be applied to the same acupoints (Fengfu GV16 and Baihui GV20) for 30 minutes per site, once daily for 12 months. Procedures, duration, and application schedule will be identical to the active treatment group to ensure blinding. The sham device does not emit far-infrared radiation. |
Who may qualify
- Ages
- 61 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Alzheimer's disease dementia.
- Mini-Mental State Examination (MMSE) score between 18 and 24 (inclusive).
- Currently prescribed and maintained on a stable regimen of anti-dementia medication.
- No sensory deficits or impairment regarding skin temperature perception.
- Patient or a Legally Authorized Representative (LAR) must be willing and capable of providing written informed consent prior to enrollment.
Key exclusion criteria (12 listed)
- Non-Alzheimer's disease dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia).
- Known hypersensitivity to heat or light, including the current use of photosensitizing medications.
- Diminished thermal or heat sensitivity, such as from the concurrent use of analgesics, sedatives, or consumption of alcoholic beverages.
- Acute injury or acute localized inflammation, including active inflammation, infection, or ulcerated wounds.
- Concomitant acute venous thrombosis, varicose veins, severe peripheral arterial occlusive disease (Stage III or IV), lymphatic disease, acute rheumatoid arthritis, acute gout, or active fever.
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 |
|---|---|---|
| Yin Fu Rui De Far-Infrared RadiatorAlso: Yin Fu Rui De Far-Infrared Radiator (Model CE-1899)The investigational device is a head-mounted far-infrared therapy device manufactured in Taiwan. * Emission wavelength: 4-14 μm * Heating mechanism: ceramic semiconductor heating element * Design: head-mounted structure with external housing to reduce energy dissipation * Application sites: Fengfu (GV16) and Baihui (GV20) Regulatory status: Approved medical device (Medical Device License No. 006083 issued by the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan). Approved indications include relief of fatigue, improvement of local blood circulation, and reduction of muscle stiffness and neuralgia. In this study, the device is used investigationally to evaluate potential effects on cognitive function in patients with Alzheimer's disease dementia. | Device | Active Far-Infrared (FIR) Therapy |
| Sham Far-Infrared RadiatorAlso: Sham Far-Infrared Device (Model CE-1889)The sham device is identical in appearance to the active device but without active far-infrared emission. It is used to maintain participant blinding and control for non-specific effects in device-based interventions. | Device | Sham Control |
Primary outcome
Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Adverse Events (AEs)
Time frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
Safety will be evaluated by tracking any unfavorable clinical occurrence associated with the use of the Yin Fu Rui De far-infrared therapy device, assessed through regular clinical physical examinations and documented via Case Report Forms (CRFs). The unit of measure is the number of participants experiencing at least one AE. Safety analysis will be performed using the Intent-to-Treat (ITT) population (N=40). Following the protocol's statistical plan, the specific clinical manifestations, severity, and device-causality of all AEs will be documented. The proportions of pre-treatment normal versus post-treatment abnormal cases, along with AE incidence rates, will be calculated and compared between the intervention and control groups using the Chi-Squared Test. Unit of Measure: Number of participants
Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Serious Adverse Events (SAEs)
Time frame: Time Frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
Safety will be evaluated by focusing on serious safety concerns associated with the use of the Yin Fu Rui De far-infrared therapy device, assessed through clinical evaluations and documented via Case Report Forms (CRFs). Serious adverse events (SAEs) are defined as events resulting in death, life-threatening conditions, prolonged hospitalization, or permanent disability. Safety analysis will be performed using the Intent-to-Treat (ITT) population (N=40). The relationship between the device and SAEs will be documented, and the proportions of pre-treatment normal versus post-treatment abnormal cases, alongside SAE incidence rates, will be statistically compared between the intervention and control groups using the Chi-Squared Test.
2 secondary outcomes
Change From Baseline in Cognitive Function Score Assessed by MMSE
Time frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
Change From Baseline in Mitochondrial Adenosine Triphosphate (ATP) Production Rate
Time frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
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 26 Jun 2026.
- BackgroundLeong, K.-I., Chen, Y.-C., & Chen, J.-H. (2014). Dementia: A focused review. Journal of Internal Medicine of Taiwan, 25(3), 151-157. https://www.mohw.gov.tw/dl-77702-2060aef3-99b0-48b0-97ff-53d1210b6acf.html
- Results publication: PubMed 35669462Chen H, Chen F, Jiang Y, Zhang L, Hu G, Sun F, Zhang M, Ji Y, Chen Y, Che G, Zhou X, Zhang Y. A Review of ApoE4 Interference Targeting Mitophagy Molecular Pathways for Alzheimer's Disease. Front Aging Neurosci. 2022 May 20;14:881239. doi: 10.3389/fnagi.2022.881239. eCollection 2022.
- Results publicationHsieh, Y.-Y., Lin, J.-P., Liu, W.-C., & Lin, C.-C. (2007). Medical applications and the action mechanisms of far-infrared ray. Taiwan Journal of Applied Radiation and Isotopes, 3(3), 333-340. https://doi.org/10.29832/TJARI.200709.0002
- Results publicationDepartment of Statistics, Ministry of Health and Welfare (September 18, 2020). World Alzheimer's Day Health and Welfare Statistics Bulletin, Department of Statistics, Ministry of Health and Welfare. https://dep.mohw.gov.tw/DOS/cp-5112-63351-113.html
- Results publication: PubMed 23833705Vatansever F, Hamblin MR. Far infrared radiation (FIR): its biological effects and medical applications. Photonics Lasers Med. 2012 Nov 1;4:255-266. doi: 10.1515/plm-2012-0034.
- Results publication: PubMed 35701825Li Q, Peng J, Luo Y, Zhou J, Li T, Cao L, Peng S, Zuo Z, Wang Z. Far infrared light irradiation enhances Abeta clearance via increased exocytotic microglial ATP and ameliorates cognitive deficit in Alzheimer's disease-like mice. J Neuroinflammation. 2022 Jun 14;19(1):145. doi: 10.1186/s12974-022-02521-y.
- Results publication: PubMed 22894755Huang PH, Chen JW, Lin CP, Chen YH, Wang CH, Leu HB, Lin SJ. Far infra-red therapy promotes ischemia-induced angiogenesis in diabetic mice and restores high glucose-suppressed endothelial progenitor cell functions. Cardiovasc Diabetol. 2012 Aug 15;11:99. doi: 10.1186/1475-2840-11-99.
- Results publication: PubMed 34138944Fukui K, Kimura S, Kato Y, Kohno M. Effects of far infrared light on Alzheimer's disease-transgenic mice. PLoS One. 2021 Jun 17;16(6):e0253320. doi: 10.1371/journal.pone.0253320. eCollection 2021.
- Results publication: PubMed 33717134Fairley LH, Wong JH, Barron AM. Mitochondrial Regulation of Microglial Immunometabolism in Alzheimer's Disease. Front Immunol. 2021 Feb 25;12:624538. doi: 10.3389/fimmu.2021.624538. eCollection 2021.
- Results publication: PubMed 25722734Chen TY, Yang YC, Sha YN, Chou JR, Liu BS. Far-Infrared Therapy Promotes Nerve Repair following End-to-End Neurorrhaphy in Rat Models of Sciatic Nerve Injury. Evid Based Complement Alternat Med. 2015;2015:207245. doi: 10.1155/2015/207245. Epub 2015 Feb 3.
- Far-Infrared Therapy Promotes Nerve Repair following End-to-End Neurorrhaphy in Rat Models of Sciatic Nerve InjuryLink provided by the sponsor.
- Mitochondrial Regulation of Microglial Immunometabolism in Alzheimer's DiseaseLink provided by the sponsor.
- Effects of far infrared light on Alzheimer's disease-transgenic miceLink provided by the sponsor.
- Far infra-red therapy promotes ischemia-induced angiogenesis in diabetic mice and restores high glucose-suppressed endothelial progenitor cell functionsLink provided by the sponsor.
- Far infrared light irradiation enhances Aβ clearance via increased exocytotic microglial ATP and ameliorates cognitive deficit in Alzheimer's disease-like miceLink provided by the sponsor.
- Far infrared radiation (FIR): its biological effects and medical applicationsLink provided by the sponsor.
- Individual participant dataSharing planned: No. To protect the privacy and confidentiality of the participants in accordance with personal data protection regulations, individual participant data (IPD) will not be publicly shared. The clinical study results will be disseminated exclusively through aggregated data in peer-reviewed scientific publications and official trial registries.
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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.
Jiunn-Tay Lee, Ｍ.D. principal investigator
Trial-Service General Hospital, National Defense Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yin Fu Rui De Far-Infrared Radiator in people with Dementia and Alzheimer Disease, run by Juin-Hong Cherng 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 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?
Contact Juin-Hong Cherng, Ph.D. (886-2-87923100 ext. 18681, 18699, i72bbb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Adverse Events (AEs) (time frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.). The study lists 2 primary outcomes in all. 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 NCT07672171, which also lists 10 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 26 Jun 2026.