Skip to main content
OpenTrials
Completed

NCT Number: NCT01883349

Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kidney Transplant

Procedure

Kidney Transplant Surgery

No kidney transplant

Other

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

Primary outcomes

  1. 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

  1. 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

  2. Change in inflammatory markers

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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2013
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.