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.

Conditions

• Dementia
• Alzheimer Disease

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Tri-Service General Hospital (TSGH)

  collaborator OTHER

• Juin-Hong Cherng

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

61 Years

Max Age

92 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-15

Primary Completion

2029-10-31

Completion

2029-10-31

Countries

• Taiwan

Study Locations