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Clinical Trials/NCT01883349
NCT01883349
Completed
Not Applicable

Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

University of Kansas Medical Center1 site in 1 country120 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
University of Kansas Medical Center
Enrollment
120
Locations
1
Primary Endpoint
Change in Cognitive Function
Status
Completed
Last Updated
last year

Overview

Brief Summary

This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
September 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in Cognitive Function

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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