A Prospective, Single-Center, Randomized, Subject-Assessor Double-Blind, Sham-Controlled, Exploratory Clinical Trial to Evaluate the Pre- and Post-Treatment Changes of HeLaXON, a Low-Dose Radiation Therapy Device, in Patients With Mild AD Dementia
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.
• At screening, participants must meet all of the following 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.
⁃ Memory Box Score of at least 0.5.
• If receiving a cholinesterase inhibitor (donepezil, galantamine, or rivastigmine) for symptomatic treatment, the participant must have been maintained on a stable dose for at least 12 weeks before the screening visit.
• Positive cerebral amyloid accumulation confirmed by amyloid PET.
• Able to undergo the cognitive assessments and imaging examinations required by the study.
• Has a caregiver who can provide information regarding the participant's overall condition and changes in cognitive and functional status.
• Written informed consent for study participation must be obtained from a legally authorized representative. If, based on the investigator's assessment of decision-making capacity, the participant is considered able to understand the purpose and procedures of the study and voluntarily express his or her wishes, written informed consent will also be obtained from the participant.