- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905619
Cognitive Impairment in Kidney Disease
Functional and Cognitive Impairment in Advanced Kidney Disease
An increasing number of Veterans are anticipated to develop chronic kidney disease (CKD) and require hemodialysis (HD) treatments as the Veteran population ages. In 2003, approximately 290,000 US citizens were receiving HD and an estimated 19 million were affected by CKD. The annual growth rate is predicted to be 7% per year with 500,000 Americans receiving HD treatment by 2010. In 2005, approximately 2500 Veterans were receiving HD with growth expected to parallel that seen in the general population. Whereas Alzheimer's disease is the leading cause of dementia in the general population, growing evidence suggests that patients with advanced CKD experience cognitive deficits related to accelerated cerebrovascular disease. Patients with advanced CKD have been shown to have a high prevalence of sub-clinical cerebrovascular damage on imaging studies and a heavy burden of vascular risk factors such as diabetes, elevated cholesterol, and hypertension. Many of the cognitive deficits related to cerebrovascular disease may go unrecognized by routine measures of cognition. HD patients have increased number of hospitalizations, and several compliance issues ranging from congestive heart failure to dangerous electrolyte imbalances. Impaired cognition in this population is likely to have a significant impact on self-care and compliance with complex medical regimens. Currently, the severity and scope of cognitive impairment related to vascular disease is not well known in patients with advanced kidney disease. Additionally, the relationship between cognitive impairment and measures of self-care independence are not well known. Loss of independence and function secondary to impaired cognitive function is likely to be a significant problem for patients with advanced kidney disease. Early identification of functional impairment, particularly instrumental activities of daily living (IADL), will allow for rehabilitation intervention. Maintaining or improving functional independence through intensive rehabilitation could translate into better compliance and lower hospitalization rate among HD patients. Information obtained from this study is likely to heighten awareness of cognitive impairment and the functional consequences in Veterans with advanced kidney disease. Primary objectives are to determine:
- The range of cognitive deficits with emphasis on domains affected by vascular disease in patients with advanced CKD and those receiving hemodialysis.
- The associations between severity of cognitive impairment and severity of kidney disease.
- The prevalence of impaired IADLs and the level of health-related quality of life (HRQOL) in patients with advanced CKD and those requiring hemodialysis.
- The relationship or association of cognitive impairment with IADL and HRQOL.
Secondary objective is to determine:
1. The relationships among cerebral and carotid blood flow, carotid artery stiffness, and renal specific metabolic abnormalities with cognitive impairment.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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New York
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The Bronx, New York, United States, 10468
- James J. Peters VA Medical Center, Bronx, NY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
PreHD Subjects:
- Male or female with an age of 18 years or older (no upper limit);
- Patients with stage III-IV CKD attending the renal primary care clinic or renal consult clinic;
- Fluent in English;
- Outpatient or stable nursing home patient
HD Subjects:
- Receiving HD for at least two weeks;
- Male or female with an age of 18 years or older (no upper limit);
- Fluent in English;
- Outpatient or stable nursing home patient
Control Subjects:
- Glomerular filtration rate of 60 cc/minute or greater;
- Male or female with an age of 18y or older (no upper limit);
- Fluent in English
- Outpatient
Exclusion Criteria:
PreHD Subjects:
- Acute illness;
- Clinical history of stroke, dementia, or Parkinson's disease;
- Hb <10;
- Liver function tests 2x upper limit of normal;
- Hemodialysis
HD Subjects:
- Acute illness;
- Clinical history of stroke, dementia, or Parkinson's disease;
- Hb <10;
- Liver function tests 2x upper limit of normal;
- URR <65% (measure of dialysis adequacy: will use 3-month average from chart)
Control Subjects:
- Acute illness;
- Clinical history of stroke, dementia, or Parkinson's disease;
- Hb <10;
- Liver function tests 2x upper limit of normal;
- Stage 3-4 CKD;
- Hemodialysis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control
No kidney disease
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PreHD kidney disease
Kidney disease stage 4 or below
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Hemodialysis
Kidney disease receiving hemodialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychological Assessments
Time Frame: 1 year
|
battery of neurocognitive tests
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: James B Post, MD, James J. Peters Veterans Affairs Medical Center
Publications and helpful links
General Publications
- Post JB, Jegede AB, Morin K, Spungen AM, Langhoff E, Sano M. Cognitive profile of chronic kidney disease and hemodialysis patients without dementia. Nephron Clin Pract. 2010;116(3):c247-55. doi: 10.1159/000317206. Epub 2010 Jul 2.
- Post JB, Morin KG, Handrakis JP, Rivera DR, Yen C, Sano M, Spungen AM. Cognition may be related to arterial pulsatility index in HD patients. Clin Nephrol. 2014 May;81(5):313-9. doi: 10.5414/cn107998.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B5050W-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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