Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function
研究概览
简要总结
This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.
详细描述
Cognitive impairment is very common in patients with End Stage Renal Disease (ESRD). It exact mechanisms are not clear, but patients with ESRD have more cerebral white matter changes. Several studies have shown that cognitive function improves post-transplant, indicating that there may be some reversibility in the process. This study will examine the correlation between cognitive impairment and structural brain changes before and after renal transplantation. We will also study the correlation of cognitive function with serum inflammatory markers before and after transplant. These results will be compared to aged matched healthy controls without kidney disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-transplant ESRD patients who are listed for renal transplantation
- •Able to sign pre-transplant consent on their own will
- •Have english as their native language
排除标准
- •Current use of antipsychotics or anti-epileptics
- •Inability to read or write which will limit their ability to perform the cognitive tests
- •Claustrophobia or inability to get MRI for other reasons
- •Unable to sign consent
结局指标
主要结局
Change in Cognitive Function
时间窗: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Cognition will be assessed using relevant neuropsychological tests used by National Alzheimers Coordination center (NACC) uniform data set (UDS). Primary outcome will be logical memory. Score range 0-25. Higher scores indicate better cognitive function.
次要结局
- Change in brain MRI(Change from Baseline to 3 Months and 12 months after Renal Transplant)
- Change in inflammatory markers(Change from Baseline to 3 months and 12 months post transplant)
- Change in verbal declarative/episodic memory(Change from Baseline to 3 Months and 12 Months after Renal Transplant)
- Change in delayed verbal declarative/episodic memory(Change from Baseline to 3 Months and 12 Months after Renal Transplant)
- Change in psychomotor speed and visuospatial function(Change from Baseline to 3 Months and 12 Months after Renal Transplant)
- Change in general dementia screening score(Change from Baseline to 3 Months and 12 Months after Renal Transplant)
- Change in working memory or attention(Change from Baseline to 3 Months and 12 Months after Renal Transplant)