Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus
- Registration Number
- NCT03703154
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
The purpose of this study is to learn if conversion from immediate release tacrolimus to Envarsus improves cerebral blood flow, brain blood flow response to exercise, and cognition.
- Detailed Description
Each patient will have two study assessments: one at baseline and another one at 12 weeks after the baseline assessment. Each assessment may be divided into 2 visits to accommodate the MRI and TCD (Transcranial Doppler ultrasound). Detailed medical history will be extracted from the patients' medical records, interviews and questionnaires. We will obtain brain MRI (without gadolinium contrast) in enrolled patients. Neuropsychological test (NP) tests will include a standard battery to detect subclinical changes in cognition which can be missed by screening tests like the mini mental state exam.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- age between 18 and 85 years
- English speaking (NP tests will be in English);
- able to sign informed consent
- able to arrange transportation to and from study sites
- without acute stroke, concussion or traumatic brain injury
- received a kidney transplant at least 12 weeks before recruitment
- stable kidney function with serum creatinine <3mg/dl
- are claustrophobic or have other contra-indication for MRI
- have hearing or visual impairment
- are unable to read, write, speak or understand English
- have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
- dual organ transplant
- oxygen-dependent chronic obstructive pulmonary disease
- diagnosis of dementia
- unable to perform exercise on the Nustep (muscle weakness or cardiac safety concern)
- uncontrolled blood pressure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Arm Envarsus The patients in the study arm will be converted from immediate release Tacrolimus to Envarsus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients. Control Arm Tacrolimus Patients in the control arm will remain on the immediate release Tacrolimus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients.
- Primary Outcome Measures
Name Time Method Change in cognitive function using a battery of neuropsychological tests Change from Baseline to Week 12 Battery aggregate scores include such tests as: Mini Mental Sate Exam, Montreal Cognitive Assessment, Digit Span, Logical Memory, Category Fluency, Trail Making, Digit Symbol, Block Design, Stroop, Buschke Free and Cued Reminding Test.
Change in cerebral blood flow Change from Baseline to Week 12 including brain blood flow response curve to exercise or cerebral reactivity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States