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.
Male or female participants aged 60 to 85 years, inclusive.
Mild dementia (Stage 4) according to the NIA-AA (New Diagnostic Criteria for Alzheimer's Disease) criteria.
K-MMSE-2 score of 20 to 26, inclusive.
CDR Global Score of 1, or CDR Global Score of 0.5 or 1 with a CDR-SB score of 4.5 to 9.0, inclusive.
Acute or subacute hemorrhage.
Prior macrohemorrhage greater than 1 cm in diameter on T2-weighted imaging, or prior subarachnoid hemorrhage, unless it can be documented that the finding is not due to an underlying structural or vascular abnormality and does not suggest a risk of recurrent hemorrhage.
More than 4 microhemorrhages.
Cortical infarct greater than 1.5 cm in diameter, irrespective of anatomical location.
Parallel
HeLaXON 1X Low-Dose Radiation Therapy
DeviceLow-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.
Sham HeLaXON 1X Procedure
DeviceThe 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.
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score
Change in ADAS-K-Cog-13 score from baseline will be evaluated at 6 and 12 months. The 13-item cognitive subscale evaluates multiple cognitive domains relevant to Alzheimer's disease. Lower scores indicate better preserved cognitive function.
Change From Baseline in Alzheimer's Disease Assessment Scale-Korea-Cognitive Subscale-13 (ADAS-K-Cog-13) Score
Change in ADAS-K-Cog-13 score from baseline will be evaluated at 6 and 12 months. The 13-item cognitive subscale evaluates multiple cognitive domains relevant to Alzheimer's disease. Lower scores indicate better preserved cognitive function.
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
Change in K-iADL score from baseline will be evaluated at 6 and 12 months. The K-iADL assesses the participant's ability to perform instrumental activities required for daily living.
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