Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia
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.
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Juin-Hong Cherng, Ph.D.
- 电话号码：18681, 18699 886-2-87923100
- 邮箱：i72bbb@gmail.com
研究联系人备份
- 姓名：Gang-Yi Fan, Ph.D.
- 电话号码：18699 886-2-8792-3100
- 邮箱：u9310318@gmail.com
学习地点
-
-
-
Taipei、台湾、11490
- 招聘中
- Trial-Service General Hospital, National Defense Medical University
-
接触：
- Gang-Yi Fan, Ph.D.
- 电话号码：18699 886-2-87923100
- 邮箱：u9310318@gmail.com
-
接触：
- Juin-Hong Cherng, Ph.D.
- 电话号码：18699, 18681 886-2-87923100
- 邮箱：i72bbb@gmail.com
-
首席研究员：
- Jiunn-Tay Lee, M.D.
-
副研究员：
- Chia-Lin Tsai, Ph.D.
-
副研究员：
- Chia-Kuang Tsai, Ph.D.
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Active Far-Infrared (FIR) Therapy
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. |
The investigational device is a head-mounted far-infrared therapy device manufactured in Taiwan.
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.
其他名称：
|
|
假比较器：Sham Control
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. |
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Adverse Events (AEs)
大体时间：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 |
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)
大体时间：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.
|
Time Frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Cognitive Function Score Assessed by MMSE
大体时间：Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
|
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) |
Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
|
|
Change From Baseline in Mitochondrial Adenosine Triphosphate (ATP) Production Rate
大体时间：Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
|
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) |
Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
|
合作者和调查者
调查人员
- 首席研究员：Jiunn-Tay Lee, Ｍ.D.、Trial-Service General Hospital, National Defense Medical University
出版物和有用的链接
一般刊物
- 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.
- Hsieh, 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.
- Li 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.
- Huang 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.
- Fukui 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.
- Fairley 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.
- Chen 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.
有用的网址
- Far-Infrared Therapy Promotes Nerve Repair following End-to-End Neurorrhaphy in Rat Models of Sciatic Nerve Injury
- Mitochondrial Regulation of Microglial Immunometabolism in Alzheimer's Disease
- Effects of far infrared light on Alzheimer's disease-transgenic mice
- Far infra-red therapy promotes ischemia-induced angiogenesis in diabetic mice and restores high glucose-suppressed endothelial progenitor cell functions
- Far infrared light irradiation enhances Aβ clearance via increased exocytotic microglial ATP and ameliorates cognitive deficit in Alzheimer's disease-like mice
- Far infrared radiation (FIR): its biological effects and medical applications
- This MOHW report highlights Taiwan's 2019-2020 dementia stats. In 2019, 235k people sought care (60.7% female; 96.3% aged 65+). By 2020, 66k held disability cards, and 58k aged 50+ used LTC 2.0. Taiwan set up 95 co-care centers and 494 sites. It ranked 1
- Dementia Prevention, Care Policy Guidelines and Action Plan 2.0 (Including Work Items, 2018-2025)
- Medical Applications and the Action Mechanisms of Far-infrared Ray
- A Review of ApoE4 Interference Targeting Mitophagy Molecular Pathways for Alzheimer's Disease
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- YIN FU RUI DE 2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.