KCT0007550招募中未知
The Multicenter Phase II Clinical Trial for Evaluation of Safety and Efficacy using Low Dose Irradiation with Alzheimer's Disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 60(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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