Far-Infrared Therapy for Alzheimer’s Disease Dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, controlled study evaluating the effects of Yin Fu Rui De Far-Infrared Radiator compared with a sham device in adults with Alzheimer's disease dementia. Eligible participants have MMSE scores 18–24 and are on stable anti-dementia medications. The study investigates potential cognitive and functional benefits from FIR exposure, with safety monitoring for heat-related and photosensitivity risks. Outcomes will help determine whether FIR therapy could be a non-pharmacologic option to support cognition and quality of life in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Trial-Service General Hospital, National Defense Medical University
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Jiunn-Tay Lee, Ｍ.D. — Trial-Service General Hospital, National Defense Medical University
• Study coordinator: Juin-Hong Cherng, Ph.D.
• Email: i72bbb@gmail.com
• Phone: 886-2-87923100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.