Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in brain amyloid deposits
研究概览
简要总结
Alzheimer's Disease (AD) is the most frequent neurodegenerative disease associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered the first molecular event occurring in AD: as already showed in an animal model, a low-dose radiotherapy (RT) course is capable of reducing AD-associated amyloid-β plaques and improve cognitive function. This pilot study wishes to investigate in 10 patients with a diagnosis of prodromal or early probable AD and with evidence of amyloid pathology the effectiveness of a short course low dose RT radiotherapy to reduce amyloid deposits in the human brain using molecular imaging (18F-Florbetapir) to show the effectiveness of the treatment on the specific target.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the clinical trial and give an informed consent
- •Clinical diagnosis of prodromal AD, or mild or moderate AD
- •Ability to undergo neurocognitive assessment at baseline visit, alone or accompanied by a caregiver
- •Amyloid PET scan positivity
- •Ability to follow the 5-days RT regiment, alone or accompanied by a caregiver
排除标准
- •Inclusion in another disease modifying clinical trial
- •Previous therapeutic brain irradiation
- •Evidence of vascular cognitive impairment on Magnetic Resonance Imaging (MRI) (Fazekas score >1 and Wahlund score >=10/30)
- •Oncologic disease (excluding skin cancer) active or in remission from less than 5 years
- •Evidence of substance abuse (alcohol and/or other drugs) with a dependence during the previous 12 months (DSM-IV criteria)
- •Presence of subdural hygroma's, subdural hematomas or hydrocephalus
- •Significant psychiatric comorbidity as assessed during the clinical evaluation by the neurologist/geriatrician in charge
- •Active or recent (within 3 months) cerebral infection/haemorrhage
- •Immunocompromised status
- •Prior history of seizure
- •Dermatological skin disease of the scalp
- •Women who are pregnant or breast feeding or who intend to become pregnant during the course of the study;
- •Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;
研究组 & 干预措施
Observation
Subjects in this arm will only be followed and not treated (observational arm)
Treatment arm
Subjects will receive a low dose brain radiotherapy
干预措施: Low dose radiotherapy (Radiation)
结局指标
主要结局
Change in brain amyloid deposits
时间窗: 8-12 weeks from end of RT
Assess intra-individual change in a quantitative measure of amyloid deposits on PET imaging (Standard Uptake Value ratio) SUVR between amyloid PET scans before and after low dose brain RT
Safety and adverse event associated with low dose brain RT
时间窗: 12 months from end of RT
Assess the number of patients who report adverse events
次要结局
- Neuropsychological performances(6 months after inclusion)
研究者
Valentina Garibotto
Pr
University Hospital, Geneva