Exploratory Study of Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Patients With Mild Alzheimer's Disease Dementia
Sponsor: ReadyCure Inc. • ClinicalTrials.gov ID: NCT07863011
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This randomized, sham-controlled, exploratory clinical trial will evaluate the efficacy and safety of HeLaXON, an investigational low-dose radiation therapy device, in patients with mild Alzheimer's disease dementia. A total of 30 participants will be randomly assigned in a 1:1 ratio to receive either low-dose whole-brain radiation therapy or a sham procedure using the same device. Participants in the treatment group will receive 0.04 Gy per session twice weekly for 3 weeks, for a total of 6 sessions and a cumulative dose of 0.24 Gy. Participants in the sham group will undergo the same device procedures without radiation delivery. Participants and outcome assessors will remain blinded to treatment assignment. Changes in cognitive function, dementia severity, daily functioning, and amyloid burden will be evaluated at 6 and 12 months after treatment. Safety will be assessed throughout the study. Exploratory blood biomarkers, including plasma Aβ42/40 ratio, p-tau217, and Aβ oligomer, will also be evaluated.
Interventions
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HeLaXON 1X Low-Dose Radiation Therapy
(Device)
Low-dose whole-brain X-ray radiation will be delivered using the HeLaXON 1X device at 0.04 Gy per session, twice weekly for 3 weeks. Participants will receive a total of 6 sessions, corresponding to a cumulative radiation dose of 0.24 Gy.
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Sham HeLaXON 1X Procedure
(Device)
The HeLaXON 1X device will be used with the same participant positioning, head and neck immobilization, device operation, sound, and lighting procedures as the experimental intervention; however, no radiation will be delivered. The total radiation dose will be 0.00 Gy.
Eligibility criteria
Conditions
Locations
- Soonchunhyang University Cheonan Hospital — Cheonan, Chungcheongnam-do, South Korea
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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