Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

University of Kansas Medical Center120 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

End Stage Renal Disease

Interventions

Kidney TransplantPROCEDURE

Kidney Transplant Surgery

No kidney transplantOTHER

The control group was made up of subjects without ESRD and were not on the renal transplantation waitlist.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Change in Cognitive Function

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.

Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant

Secondary Outcomes

Change in brain MRI

Brain MRI will be performed before and after transplant

Time frame: Change from Baseline to 3 Months and 12 months after Renal Transplant

Change in inflammatory markers

Time frame: Change from Baseline to 3 months and 12 months post transplant

Change in verbal declarative/episodic memory

WMS-R Logical Memory I- Immediate is a test where a brief story is read to subject, who is then asked to retell it from memory immediately; primary measure of performance is number of story units recalled. Scores are from 0-25 with higher scores indicating better cognition.

Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant

Change in delayed verbal declarative/episodic memory

WMS-R Logical Memory II- Delayed measures delayed recall of story read to the participant at the beginning of testing session (WMS-R Logical Memory I- Immediate). Scores range from 0-25 with higher scores indicating better cognition.

Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant

Change in psychomotor speed and visuospatial function

WAIS-R Digit Symbol Substitution test is where a subject is given a key consisting of numbers 1-9, each paired with a unique, easy-to-draw symbol; subject fills in corresponding symbol for each number in a limited time. Scores are from 0-133 with higher scores indicating better cognition.

Data from ClinicalTrials.gov

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