Clinical trial NCT01883349: Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
Official title: Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients from the renal transplant waiting list at University of Kansas Medical Center. They will be tested before renal transplant and 3 months and 12 months after renal transplantation.

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.

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

Primary outcomes:
measure: Change in Cognitive Function
timeFrame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Secondary outcomes:
measure: Change in brain MRI
timeFrame: Change from Baseline to 3 Months and 12 months after Renal Transplant
measure: Change in inflammatory markers
timeFrame: Change from Baseline to 3 months and 12 months post transplant
measure: Change in verbal declarative/episodic memory
timeFrame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
measure: Change in delayed verbal declarative/episodic memory
timeFrame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
measure: Change in psychomotor speed and visuospatial function
timeFrame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
measure: Change in general dementia screening score
timeFrame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
measure: Change in working memory or attention
timeFrame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Aditi Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lepping RJ, Montgomery RN, Sharma P, Mahnken JD, Vidoni ED, Choi IY, Sarnak MJ, Brooks WM, Burns JM, Gupta A. Normalization of Cerebral Blood Flow, Neurochemicals, and White Matter Integrity after Kidney Transplantation. J Am Soc Nephrol. 2021 Jan;32(1):177-187. doi: 10.1681/ASN.2020050584. Epub 2020 Oct 16.
citation: Gupta A, Lepping RJ, Yu AS, Perea RD, Honea RA, Johnson DK, Brooks WM, Burns JM. Cognitive Function and White Matter Changes Associated with Renal Transplantation. Am J Nephrol. 2016;43(1):50-7. doi: 10.1159/000444334. Epub 2016 Feb 20.