NCT07672171

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
40mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Oct 2022Oct 2029

Study Start

First participant enrolled

October 15, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

June 26, 2026

Status Verified

May 1, 2026

Enrollment Period

7 years

First QC Date

June 3, 2026

Last Update Submit

June 23, 2026

Conditions

DementiaAlzheimer Disease

Keywords

Far-infrared therapyDementiaAlzheimer disease

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    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

    Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.

  • Change From Baseline in Mitochondrial Adenosine Triphosphate (ATP) Production Rate

    Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.

Study Arms (2)

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.

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.

Device: Sham Far-Infrared Radiator

Interventions

Yin Fu Rui De Far-Infrared RadiatorDEVICE

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.

Also known as: Yin Fu Rui De Far-Infrared Radiator (Model CE-1899)
Active Far-Infrared (FIR) Therapy
Sham Far-Infrared RadiatorDEVICE

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.

Also known as: Sham Far-Infrared Device (Model CE-1889)
Sham Control

Eligibility Criteria

Age61 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trial-Service General Hospital, National Defense Medical University

Taipei, 11490, Taiwan

RECRUITING

Related Publications (10)

  • 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

    BACKGROUND

  • 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.

    PMID: 35669462RESULT

  • 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

    RESULT

  • 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

    RESULT

  • 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.

    PMID: 23833705RESULT

  • 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.

    PMID: 35701825RESULT

  • 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.

    PMID: 22894755RESULT

  • 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.

    PMID: 34138944RESULT

  • 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.

    PMID: 33717134RESULT

  • 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.

    PMID: 25722734RESULT

Related Links

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Jiunn-Tay Lee, Ｍ.D.

    Trial-Service General Hospital, National Defense Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juin-Hong Cherng, Ph.D.

CONTACT

886-2-87923100i72bbb@gmail.com

Gang-Yi Fan, Ph.D.

CONTACT

886-2-8792-3100u9310318@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 26, 2026

Study Start

October 15, 2022

Primary Completion (Estimated)

October 31, 2029

Study Completion (Estimated)

October 31, 2029

Last Updated

June 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

TW(1)