NeuroFLiPP - Parametric PET of Neuroinflammation in Fatty Liver Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Alzheimer's Disease and related dementias (ADRD) affect about 6 million people in the U.S. and are the fifth leading cause of death for adults over 65. Recent research is investigating how chronic liver diseases like Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which affects one-third of the U.S. population, might influence ADRD through the liver-brain axis. MASLD shares risk factors with Alzheimer's, such as diabetes and hypertension, and studies have linked MASLD to increased risks of cognitive decline and ADRD. Mouse-model studies suggest that chronic liver inflammation in MASLD can induce neuroinflammation and accelerate Alzheimer's pathology, highlighting the importance of studying the liver-brain connection to identify new therapeutic targets for ADRD. The goal of this research is to develop a practical PET imaging method using 18F-FDG to simultaneously assess liver and brain inflammation in patients with MASLD-related ADRD. This approach leverages dynamic FDG-PET scanning and advanced tracer kinetic modeling to quantify glucose transport, overcoming limitations of traditional imaging methods that cannot noninvasively assess chronic liver inflammation. The new method aims to enable comprehensive imaging of liver-brain inflammation crosstalk, validated against the 18F-DPA-714 radiotracer. Success in this project could provide a valuable imaging tool for linking liver inflammation with neuroinflammation and cognitive decline, advancing clinical research and potentially uncovering new pathways for ADRD treatment

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants \>=18 years age

• Participants who have or have planned a liver biopsy as:

‣ standard of care for fatty liver disease with risk factors for metabolic dysfunction-associated steatohepatitis (MASH), or

⁃ as part of another Clinical Trials study for MASH, or

⁃ standard of care prior to undergoing bariatric surgery

⁃ Liver biopsy needs to be within 6 months of planned study-related imaging

• Ability to provide informed consent.

Locations
United States
California
UC Davis EXPLORER Molecular Imaging Center
RECRUITING
Sacramento
Contact Information
Primary
Dana Little, MS
dalittle@ucdavis.edu
916-734-7749
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2027-07
Participants
Target number of participants: 12
Treatments
Experimental: Imaging
Participants will undergo positron emission tomography scans. One scan will be performed after administration of 18F-FDG while the other will be perfomred after administration of 18F-DPA-714.
Sponsors
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov