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

Launched by KYUNG HEE UNIVERSITY HOSPITAL AT GANGDONG · Nov 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of low-dose irradiation (a type of radiation treatment) on patients with Alzheimer's disease. Researchers want to see if this treatment is safe and effective for improving symptoms of Alzheimer's, particularly for those who have mild forms of the disease. The trial is currently looking for participants aged 60 to 85 who have been diagnosed with Alzheimer's and have been stable on certain medications for at least three months. To be eligible, participants must also have specific brain imaging results that confirm the presence of amyloid, a substance that can build up in the brains of people with Alzheimer's.

Participants in this trial can expect to receive low-dose radiation to their whole brain, and the study will monitor their health and any changes in their cognitive abilities over time. It's important to note that some individuals will not be able to participate, such as those with a history of brain radiation or certain medical conditions. If you or a loved one fits the eligibility criteria and are interested in learning more, this trial could provide a chance to explore a new type of treatment for Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All of the following criteria are satisfied for the subjects to be included in the study:
• • 1. Aged between 60 and 85 years.
• • 2. 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).
• • 3. Stably maintaining the general AD drug treatment (donepezil, galantamine, rivastigmine, or memantine) for more than 3 months.
• • 4. Amyloid accumulation in brain confirmed by Amyloid PET.
• • 5. 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)).
• • 6. Able to perform cognitive function tests and imaging tests.
• • 7. Accompanied by a guardian who provides information on the subject's overall status, cognitive function, and functional changes.
• • 8. Written informed consent was provided by the subject or the guardian to participate in this trial.
• Exclusion Criteria:
• Subjects who fall under any of the following criteria are excluded from the study:
• • 1. Previous history of radiation to the brain.
• • 2. History of seizure within the previous 10 years of the screening time.
• • 3. Skin disease on the scalp.
• • 4. Previous history of malignancy.
• • 5. Pregnancy or breastfeeding.
• • 6. 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).
• • 7. Clinically significant, unstable mental illness (i.e., uncontrolled depression, schizophrenia, and bipolar disorder) within the last 6 months.
• • 8. 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.
• • 9. 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.

Trial Officials