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Cognitive Assessment and Brain Function Evaluation in Patients With Non-alcoholic Fatty Liver Disease

Y

Yan Bi

Status

Invitation-only

Conditions

Cognitive Impairment
Non-Alcoholic Fatty Liver Disease

Treatments

Radiation: Cognitive assessment, functional magnetic resonance imaging

Study type

Observational

Funder types

Other

Identifiers

NCT05563259
NAFLDCOG

Details and patient eligibility

About

The purpose of this study is to explore the relationship between Non-alcoholic fatty liver disease and cognitive impairment and evaluate the effect of metabolic surgery or lifestyle intervention on cognition.

Full description

Previous research has shown that Non-alcoholic fatty liver disease (NAFLD) is associated with an increased risk of cognitive impairment. Even though there are many noninvasive tests available, a liver biopsy is still required for the accurate diagnosis of NAFLD. However, there are now few studies on cognitive function in patients with NAFLD based on pathological diagnosis. On one hand, in the cross-sectional study, biometric measurements, cognitive assessment, magnetic resonance imaging (MRI) results are analysed to explore the differences among control subjects and NAFLD patients undergoing liver biopsy. One the other hand, in the longitudinal study, changes in cognitive scales and MRI results in NAFLD patients both at baseline and 12-48 months after intervention are collected to investigate whether surgical intervention and weight control benefit brain function.

Enrollment

500 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • >6 years of education
  • right handed

Exclusion criteria

  • consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females)
  • with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis
  • with thyroid diseases
  • in a state of anxiety or depression
  • inability to complete cognitive function scales

Trial design

500 participants in 3 patient groups

Groups/Cohorts Interventions Control
Description:
patients with steatosis \< 5%
Treatment:
Radiation: Cognitive assessment, functional magnetic resonance imaging
non-NASH
Description:
patients with steatosis ≥ 5% and did not achieve the criteria for NASH
Treatment:
Radiation: Cognitive assessment, functional magnetic resonance imaging
NASH
Description:
patients with NAFLD Activity Score (NAS) ≥ 5
Treatment:
Radiation: Cognitive assessment, functional magnetic resonance imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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