Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

October 4, 2024 updated by: University of Kansas Medical Center
This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ESRD patients
ESRD patients awaiting renal transplantation
Procedure: Kidney Transplant
Kidney Transplant Surgery
Control Arm
Subjects without kidney disease. No intervention with control group.
Other: No kidney transplant
The control group was made up of subjects without ESRD and were not on the renal transplantation waitlist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to 3 Months and 12 Months after Renal Transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain MRI
Time Frame: Change from Baseline to 3 Months and 12 months after Renal Transplant
Brain MRI will be performed before and after transplant
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 from Baseline to 3 months and 12 months post transplant
Change in verbal declarative/episodic memory
Time Frame: 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 from Baseline to 3 Months and 12 Months after Renal Transplant
Change in delayed verbal declarative/episodic memory
Time Frame: 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 from Baseline to 3 Months and 12 Months after Renal Transplant
Change in psychomotor speed and visuospatial function
Time Frame: 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 from Baseline to 3 Months and 12 Months after Renal Transplant
Change in general dementia screening score
Time Frame: 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 from Baseline to 3 Months and 12 Months after Renal Transplant
Change in working memory or attention
Time Frame: 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.
Change from Baseline to 3 Months and 12 Months after Renal Transplant

Other Outcome Measures

Outcome Measure
Time Frame
Change in brain MRI findings and serum inflammatory markers post transplantation and its correlation with cognition
Time Frame: Change from Baseline to 3 Months after Renal Transplant
Change from Baseline to 3 Months after Renal Transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Aditi Gupta, MD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimated)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13566

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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