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Life sciences · Interventional Study
ClinicalTrials.gov · October 7, 2026
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Interventional Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07863011). This is a study registration, not published results. Lead sponsor: ReadyCure Inc.. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Alzheimer Disease. Interventions: DEVICE: HeLaXON 1X Low-Dose Radiation Therapy; DEVICE: Sham HeLaXON 1X Procedure. Primary outcome measures: Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score , Baseline to 6 months and 12 months after the intervention; Change From Baseline in Alzheimer's Disease Assessment Scale-Korea-Cognitive Subscale-13 (ADAS-K-Cog-13) Score , Baseline to 6 months and 12 months after the intervention; Change From Baseline in Korean Mini-Mental Status Examination-2 (K-MMSE-2) Score , Change in K-MMSE-2 score from baseline will be evaluated at 6 and 12 months. The K-MMSE-2 is used to assess global cognitive function and changes in cognitive status over time.; Change From Baseline in Korean Instrumental Activities of Daily Living (K-iADL) Score , Baseline to 6 months and 12 months after the intervention; Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale , Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale. Brief summary: 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.