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To Explore the Effect of Far Infrared Therapy on Cognitive Function of Patients With Dementia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 61
Maximum Age: 92
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Trial-Service General Hospital, National Defense Medical University
RECRUITING
Taipei
Contact Information
Primary
Juin-Hong Cherng, Ph.D.
i72bbb@gmail.com
886-2-87923100
Backup
Gang-Yi Fan, Ph.D.
u9310318@gmail.com
886-2-8792-3100
Time Frame
Start Date: 2022-10-15
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 40
Treatments
Experimental: Active Far-Infrared (FIR) Therapy
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.
Sham_comparator: Sham Control
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.
Sponsors
Leads: Juin-Hong Cherng
Collaborators: Tri-Service General Hospital (TSGH)

This content was sourced from clinicaltrials.gov