The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy on Brain Amyloidosis During the Treatment of Mild or Moderate Alzheimer's Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods
研究概览
简要总结
Alzheimer's disease is the most frequent neurocognitive disorder associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered as the first molecular event on the onset of Alzheimer's disease. It has already been demonstrated that low-dose radiotherapy is capable of reducing Alzheimer's disease-associated amyloid-β plaques and improving cognitive function in an animal model. In human, low-dose radiotherapy has demonstrated effectiveness in reducing bronchial amyloidosis.
The present study aims to conduct research by including 10 patients with a diagnosis of mild or moderately severe Alzheimer's disease and with evidence of amyloid pathology. Furthermore, the aim is to demonstrate the effectiveness of low-dose radiotherapy in reducing amyloid deposits in the human brain using molecular imaging (Flutemetamol(18F) PET) along with treatment of the specific target.
详细描述
The investigators decided to use fractionated whole brain radiation doses of 1.8 Gy x 5 and 1.8 Gy x 3. Subjects will be followed with neurocognitive testing at 6 months post radiotherapy.
subjects 1-5 - 9Gy in 5 daily fractions
subjects 6-10 - 5.4Gy in 3 daily fractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of mild or moderate Alzheimer's disease.
- •Amyloid PET scan positivity.
- •Korean Mini-Mental State Examination score ≥10 and ≤
- •Clinical dementia rating scale 0.5, 1 or
- •Ability to undergo neurocognitive assessment at baseline visit, alone or accomparined by a caregiver.
- •Ability to understand the clinical trial and give an informed consent
排除标准
- •previous therapeutic whole brain irradiation
- •Evidence of seizure activity
- •Evidence of active dermatological skin disease of the scalp.
- •History of malignant tumors.
- •Pregnant or breastfeeding.
- •If the researcher determines that participation in this study is inadequate because of other findings that are considered clinically important.
结局指标
主要结局
Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods
时间窗: 6 months after the first visit.
verification of radiation therapy effect through GDS test
次要结局
- change in brain amlyoid deposits(6 months after the first visit)