Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

Completed

• Conditions: End Stage Renal Disease
• Interventions: Procedure: Kidney Transplant; Other: No kidney transplant

• Registration Number: NCT01883349
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-21
• Primary Completion: 2023-07
• Study Completion: 2023-09
• Status Verified: 2023-12
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ESRD patients	Kidney Transplant	ESRD patients awaiting renal transplantation
Control Arm	No kidney transplant	Subjects without kidney disease. No intervention with control group.

Primary Outcome Measures

Name	Time	Method
Change in Cognitive Function	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 Outcome Measures

Name	Time	Method
Change in brain MRI	Change from Baseline to 3 Months and 12 months after Renal Transplant	Brain MRI will be performed before and after 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	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.
Change in delayed verbal declarative/episodic memory	Change from Baseline to 3 Months and 12 Months after Renal Transplant	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.
Change in psychomotor speed and visuospatial function	Change from Baseline to 3 Months and 12 Months after Renal Transplant	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.
Change in general dementia screening score	Change from Baseline to 3 Months and 12 Months after Renal Transplant	Mini-Mental State Examination Screening scale evaluates orientation to place, orientation to time, registration, attention and concentration, recall, language, and visual construction. Scores range from 0-30 with higher scores indicate better cognition.
Change in working memory or attention	Change from Baseline to 3 Months and 12 Months after Renal Transplant	Digit Span forward and backward are tests where a subject is read sequences of increasing length and asked to repeat them. Digit span length is the length of the highest digit sequence the subject is able to repeat correctly. Scores range from 0-12 with higher scores indicate better cognition.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States