Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age61-92
SponsorJuin-Hong Cherng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Yin Fu Rui De Far-Infrared Radiator
DeviceThe 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 Radiator
DeviceThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active Far-Infrared (FIR) TherapyExperimental treatment 1 intervention
Group B: Sham ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.2
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
Time Frame: Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.Secondary outcomes
1
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)
Time frame
Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.2
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)
Time frame
Baseline (Day 1), Month 1, Month 3, and Month 12 for each participant.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Juin-Hong Cherng
Lead sponsor
National Defense Medical Center, Taiwan
Sponsor institution
Tri-Service General Hospital
Collaborator
Source ClinicalTrials.gov