The Clinical Trial of Low Dose Irradiation for Alzheimer's Disease
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0007550
- Lead Sponsor
- Kyung Hee University Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Changes in cognitive function test score compared to baseline after six months are estimated using Alzheimer’s disease assessment scale-Korea (ADAS-K). The amount of change is evaluated as a valid response if it shows an improvement of 5% or more compared to the baseline score. 2) Number of adverse events 6 months after baseline determined by the Radiation Therapy Oncology Group (RTOG) toxicity grading system.
- Secondary Outcome Measures
Name Time Method If the cognitive function tests such as Korean-Mini-Mental Status Examination (K-MMSE), Clinical Dementia Rating scale (CDR), Caregiver Administered-Neuropsychiatric Inventory (CGA-NPI), Korean Intstrumental Activities of Daily Living (K-iADL) showed an improvement of 5% or more after six months, it was evaluated as an effective response.;Changes in the standardized uptake value ratio (SUVR) of the amyloid PET in the frontal, parietal, lateral temporal, anterior wedge lobe, and the posterior gyrus are evaluated. It was considered as an effective response if the change of SUVR shows an improvement of 5% or more 6 months after the completion of LDIR.