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Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia

23 czerwca 2026 zaktualizowane przez: Juin-Hong Cherng

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Juin-Hong Cherng, Ph.D.
  • Numer telefonu: 18681, 18699 886-2-87923100
  • E-mail: i72bbb@gmail.com

Kopia zapasowa kontaktu do badania

  • Nazwa: Gang-Yi Fan, Ph.D.
  • Numer telefonu: 18699 886-2-8792-3100
  • E-mail: u9310318@gmail.com

Lokalizacje studiów

  • Tajwan
      • Taipei, Tajwan, 11490
        • Rekrutacyjny
        • Trial-Service General Hospital, National Defense Medical University
        • Kontakt:
        • Kontakt:
          • Juin-Hong Cherng, Ph.D.
          • Numer telefonu: 18699, 18681 886-2-87923100
          • E-mail: i72bbb@gmail.com
        • Główny śledczy:
          • Jiunn-Tay Lee, M.D.
        • Pod-śledczy:
          • Chia-Lin Tsai, Ph.D.
        • Pod-śledczy:
          • Chia-Kuang Tsai, Ph.D.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Diagnosed with Alzheimer's disease dementia.
  2. Mini-Mental State Examination (MMSE) score between 18 and 24 (inclusive).
  3. Currently prescribed and maintained on a stable regimen of anti-dementia medication.
  4. No sensory deficits or impairment regarding skin temperature perception.
  5. Patient or a Legally Authorized Representative (LAR) must be willing and capable of providing written informed consent prior to enrollment.

Exclusion Criteria:

  1. Non-Alzheimer's disease dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia).
  2. Known hypersensitivity to heat or light, including the current use of photosensitizing medications.
  3. Diminished thermal or heat sensitivity, such as from the concurrent use of analgesics, sedatives, or consumption of alcoholic beverages.
  4. Acute injury or acute localized inflammation, including active inflammation, infection, or ulcerated wounds.
  5. 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.
  6. Presence of mottled erythema or other abnormal dermatological conditions on the scalp or neck.
  7. Localized skin lesions, damage, or open wounds at the device contact sites.
  8. Concurrent participation in any other clinical trial.
  9. Any other underlying pathological conditions or clinical statuses that, based on medical consensus, would preclude safe participation in the study.
  10. Failure or refusal to provide signed informed consent.
  11. Inability or unwillingness to comply with the trial protocols, schedules, or required follow-up evaluations.
  12. History or presence of hemorrhagic disorders or bleeding-related diseases.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: Yin Fu Rui De Far-Infrared Radiator

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.

Inne nazwy:
  • Yin Fu Rui De Far-Infrared Radiator (Model CE-1899)
Pozorny komparator: 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.
Urządzenie: Sham Far-Infrared Radiator

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.

Inne nazwy:
  • Sham Far-Infrared Device (Model CE-1889)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Adverse Events (AEs)
Ramy czasowe: 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)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Cognitive Function Score Assessed by MMSE
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Juin-Hong Cherng

Współpracownicy

Tri-Service General Hospital

Śledczy

  • Główny śledczy: Jiunn-Tay Lee, Ｍ.D., Trial-Service General Hospital, National Defense Medical University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 października 2022

Zakończenie podstawowe (Szacowany)

31 października 2029

Ukończenie studiów (Szacowany)

31 października 2029

Daty rejestracji na studia

Pierwszy przesłany

3 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

26 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • YIN FU RUI DE 2026

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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