Exploratory Study of Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Patients With Mild Alzheimer's Disease Dementia
Condition(s) studied
Investigational drug(s) / intervention(s)
HeLaXON 1X Low-Dose Radiation Therapy: 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.
Sham HeLaXON 1X Procedure: 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.
Study 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.
Eligibility
Primary outcome measure(s)
- 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 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 — Baseline to 6 months and 12 months after the intervention
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 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 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. - Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale — Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale
Change in cerebral amyloid burden from baseline will be assessed at 6 and 12 months. Amyloid PET images will be analyzed to obtain standardized uptake value ratios (SUVRs), which will be converted to the standardized Centiloid scale.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Soonchunhyang University Cheonan Hospital | Cheonan | Chungcheongnam-do | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07863011 on ClinicalTrials.gov ↗ ← All trials in South Korea