NCT07672171 · RECRUITING
Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia
This trial is testing whether a far-infrared light-emitting device worn on the head or neck can support cognitive function in people already diagnosed with Alzheimer's dementia. Participants are randomly assigned to either the real device or a sham version. It is a Phase NA trial, meaning this is more of a controlled feasibility or efficacy study rather than a standard drug-approval phase — the device is non-pharmaceutical and does not require the same regulatory pathway.
You may qualify if
- 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.
You're excluded if
- Non-Alzheimer's disease dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia).
- Known hypersensitivity to heat or light, including the current use of photosensitizing medications.
- Diminished thermal or heat sensitivity, such as from the concurrent use of analgesics, sedatives, or consumption of alcoholic beverages.
- Acute injury or acute localized inflammation, including active inflammation, infection, or ulcerated wounds.
- 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.
- Presence of mottled erythema or other abnormal dermatological conditions on the scalp or neck.
- Localized skin lesions, damage, or open wounds at the device contact sites.
- Concurrent participation in any other clinical trial.
- Any other underlying pathological conditions or clinical statuses that, based on medical consensus, would preclude safe participation in the study.
- Failure or refusal to provide signed informed consent.
- Inability or unwillingness to comply with the trial protocols, schedules, or required follow-up evaluations.
- History or presence of hemorrhagic disorders or bleeding-related diseases.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-26