Use of Gocovri to Improve Disability Due to Radiation Encephalopathy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in the level of disability as measured by the Disability Rating Scale(DRS)
研究概览
简要总结
A study to assess the effect of Gocovri (extended-release amantidine) to improve disability as assessed by the disability rating scale (DRS) and cognition as assessed by the Montreal Cognitive Assessment (MoCA) test in patients with radiation encephalopathy.
详细描述
This is a prospective study to assess the effect of Gocovri (extended-release amantidine) on disability and cognition in patients with radiation encephalopathy. Patients with radiation encephalopathy will be seen in the office, and both clinical and short structured neuropsychological assessments will be collected longitudinally as medication adjustments are performed over time. The investigators will also measure functional glutamate activity in these subjects through use of F-FPEB PET/CT, which identifies mGluR5 expression in the brain. This imaging tracer serves as a surrogate for neurodegeneration in other conditions, such as Parkinson's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals ≥ 18 years of age.
- •Individuals with caregivers who are able to complete survey assessments for this study.
- •Prior brain radiation treatment.
- •Evidence of moderate-severe confluent white matter hyperintensity on MRI brain scan as judged by neuroradiology impression 0-5 years prior to enrollment.
- •The effects of Gocovri on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (e.g. hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; female subjects will be required to demonstrate a negative urine pregnancy test prior to study entry and subjects who are lactating should be excluded.
排除标准
- •Pregnant or breastfeeding.
- •Patients with growing brain lesions or those requiring escalating doses of tumor-directed treatment..
- •Patients requiring doses of Dexamethasone higher than 4 mg or escalating doses of Dexamethasone
- •Patients taking Amantadine or with prior usage of Amantadine.
- •Patients taking other dopaminergic, GABAergic, glutamatergic, or noradrenergic drugs.
- •Patients with a history of suicidality and depression.
- •Patients with end stage renal disease (creatinine clearance less than 15 mL/min/1.73 m2).
研究组 & 干预措施
Gocovri (extended-release amantidine)
干预措施: Gocovri (extended-release amantidine) (Drug)
结局指标
主要结局
Change in the level of disability as measured by the Disability Rating Scale(DRS)
时间窗: Baseline - 24 weeks.
The Disability Rating Scale (DRS) is a tool used to evaluate impairment, disability and handicap caused by brain injury. Scores range from 0 (No disability) to a maximum of 29 (indicating an extreme vegetative state).
次要结局
- Change in 18F-FPEB avidity on PET/CT.(Baseline - 24 weeks.)
- Change in cognition based on the MoCA test.(Baseline - 24 weeks.)