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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13566

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