Validation of Cognitive Tests in Elderly Cirrhotic Patients

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Open for enrollment

Contact information:

Megan Kelly

(480)342-1248

Kelly.Megan1@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20408131

Mayo Clinic Footer