The Clinical Trial of Low Dose Irradiation for Alzheimer's Disease

Prior treatment

• Previous history of radiation to the brain.
• History of seizure within the previous 10 years of the screening time.
• Subjects whose brain MRI confirms evidence of: acute or subacute hemorrhage, prior macro hemorrhage (defined as \>1 cm in diameter, T2 sequence) or prior subarachnoid hemorrhage unless it can be documented that the finding is not due to an underlying structural or vascular abnormality, more than 4 microhemorrhages, cortical infarct (defined as \>1.5 cm in diameter, irrespective of anatomic location), \>1 lacunar infarct (defined as \>1.5 cm in diameter), superficial siderosis, and history of diffuse white matter disease as defined by a score of 3 on the age-related white matter changes scale. Any finding that, in the opinion of the investigator, might be a contributing cause of the subject's dementia, or pose a risk to the subject, or might prevent a satisfactory MRI assessment for safety monitoring are also included in the exclusion criteria.

Other illness

• Skin disease on the scalp.
• Previous history of malignancy.
• Subjects with cognitive decline associated with drugs or neurological / neurodegenerative conditions, not AD (i.e., drug abuse, vitamin B12 deficiency, thyroid dysfunction, stroke or other cerebrovascular conditions, Lewy body dementia, frontotemporal dementia, and head trauma).
• Clinically significant, unstable mental illness (i.e., uncontrolled depression, schizophrenia, and bipolar disorder) within the last 6 months.

Other

• Subjects who fall under any of the following criteria are excluded from the study:
• Pregnancy or breastfeeding.
• Those who have other findings that are considered clinically important, and those who are judged by the researcher to be inappropriate for participation in this study.

• All of the following criteria are satisfied for the subjects to be included in the study:
• Aged between 60 and 85 years.
• Diagnosed with probable Alzheimer's disease (AD) dementia based on the new diagnostic criteria for Alzheimer's disease outlined by the National Institute on Aging and Alzheimer's Association (NIA-AA).
• Stably maintaining the general AD drug treatment (donepezil, galantamine, rivastigmine, or memantine) for more than 3 months.
• Amyloid accumulation in brain confirmed by Amyloid PET.
• Mild AD (score range of 13 to 24 on the Korean Mini-Mental State Examination (K-MMSE) or 0.5 or 1 on the Clinical Dementia Rating scale (CDR)).
• Able to perform cognitive function tests and imaging tests.
• Accompanied by a guardian who provides information on the subject's overall status, cognitive function, and functional changes.
• Written informed consent was provided by the subject or the guardian to participate in this trial.