Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia

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.

Conditions3

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