Recruiting
Not applicable
Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia
Condition(s) studied
DementiaAlzheimer Disease
Investigational drug(s) / intervention(s)
Yin Fu Rui De Far-Infrared RadiatorSham Far-Infrared Radiator
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.
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Adverse Events (AEs) — 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
- Number of Participants With Yin Fu Rui De Far-Infrared Therapy Device-Related Serious Adverse Events (SAEs) — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Trial-Service General Hospital, National Defense Medical University |
Taipei |
Taiwan |
Recruiting |
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