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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Juin-Hong Cherng, Ph.D.
- Telefonní číslo: 18681, 18699 886-2-87923100
- E-mail: i72bbb@gmail.com
Studijní záloha kontaktů
- Jméno: Gang-Yi Fan, Ph.D.
- Telefonní číslo: 18699 886-2-8792-3100
- E-mail: u9310318@gmail.com
Studijní místa
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Taipei, Tchaj-wan, 11490
- Nábor
- Trial-Service General Hospital, National Defense Medical University
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Kontakt:
- Gang-Yi Fan, Ph.D.
- Telefonní číslo: 18699 886-2-87923100
- E-mail: u9310318@gmail.com
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Kontakt:
- Juin-Hong Cherng, Ph.D.
- Telefonní číslo: 18699, 18681 886-2-87923100
- E-mail: i72bbb@gmail.com
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Vrchní vyšetřovatel:
- Jiunn-Tay Lee, M.D.
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Dílčí vyšetřovatel:
- Chia-Lin Tsai, Ph.D.
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Dílčí vyšetřovatel:
- Chia-Kuang Tsai, Ph.D.
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: 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.
Ostatní jména:
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Falešný srovnávač: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Adverse Events (AEs)
Časové okno: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
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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.
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Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Serious Adverse Events (SAEs)
Časové okno: Time Frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
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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.
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Time Frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Cognitive Function Score Assessed by MMSE
Časové okno: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
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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.
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Change From Baseline in Mitochondrial Adenosine Triphosphate (ATP) Production Rate
Časové okno: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.
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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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jiunn-Tay Lee, Ｍ.D., Trial-Service General Hospital, National Defense Medical University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Užitečné odkazy
- 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
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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