Validation of Cognitive Tests in Elderly Cirrhotic Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 17-010793
Sponsor Protocol Number: 17-010793
About this study
The purpose of this study is to define the prevalence and impact of cognitive impairment and their impact on HRQOL in elderly patients with cirrhosis compared to elderly patients without cirrhosis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
Group 1: Elderly Controls
- Age Between 65 and 95 with Preserved activities of daily living
- Able to give consent for study
- MME_>25
- Without Evidence of MCI and/or Chronic Liver Disease/cirrhosis
Group 2: Elderly Cirrhosis
- Age Between 65and 95 years
- Able to give consent
- Clinically or biopsy proven cirrhosis
Exclusion Criteria:
Group 1: Elderly Controls
- Unable to give informed consent
- Alcohol/illicit drug abuse within 3 months
- History of mental illness disorders (bipolar, schizophrenia, uncontrolled depression BDI>20, seizure disorder), cerebrovascular disease (stroke), progressive neurological diseases (severe neuropathy, Parkinson’s, Multiple sclerosis etc). Serious liver (cirrhosis, hepatitis of any kind, fatty liver without >3 ULN AST and ALT ok), kidney (CKD > stage II), heart (any uncontrolled CAD, CHF, AFib and other serious arrhythmias), respiratory (COPD, IPF), endocrine (DM if last hemoglobin Aic >7.5), or metabolic diseases (osteoporosis is ok)
- Current therapy with Galantamine and Aricept or other therapies directed for dementia
- Use of anti-psychotics and any anti-seizure medications
Group 2: Elderly Cirrhosis
- Not able to give consent
- Alcohol and Illicit drug use within the last 3 months of study
- TIPS within the last 3 months
- Focal neurological deficits noted in the medical chart
- Use of any anti-psychotics and anti-seizure medications
- History of mental illness disorders (bipolar, schizophrenia, uncontrolled depression BDI>20, seizure disorder), cerebrovascular disease (stroke), progressive neurological diseases (severe neuropathy, Parkinson’s, Multiple sclerosis etc). Serious kidney (CKD > stage II), heart (any uncontrolled CAD, CHF, AFib and other serious arrhythmias), respiratory (COPD, IPF), endocrine (DM if last hemoglobin Aic >7.5), or metabolic diseases (osteoporosis is ok).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Hugo Vargas, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available