NeuroFLiPP: Parametric PET of Neuroinflammation in Fatty Liver Disease

NCT06453915 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2175242
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

• results of 18F-FDG scans compared with results of DPA-714 scans

  validate the 18F-FDG method for assessing neuroinflammation in MASLD/MASH using 18F-DPA-714 as the reference

  3 months

Secondary Outcomes (1)

• Compare levels of neuroinflammation detected using FDG and DPA-714 scans to the levels of liver inflammation determined through biopsies

  3 months

Other Outcomes (1)

• results from PET scans compared with Brain MRI and neurocognitive testing

  3 months

Study Arms (1)

Imaging

EXPERIMENTAL

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.

Drug: 18F-DPA-714; Drug: 18F-FDG

Interventions

18F-DPA-714 DRUG

positron emission tomography scan using 18F-DPA-714 as an imaging tracer.

Imaging

18F-FDG DRUG

positron emission tomography scan using 18F-FDG as an imaging tracer.

Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease other than non-alcoholic fatty liver disease.
• Uncontrolled claustrophobia
• Body weight \>225 kg due to limitations of the scanner bed
• Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET/CT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy is available)
• Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
• Prisoners
• Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.
• Pre-existing neurodegenerative disorders and dementia
• Significant history of major skull concussion or repetitive head trauma
• Currently on anticoagulant therapy
• Metal implants (e.g., pacemaker) or claustrophobia that would preclude MRI scans

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Guobao Wang, PhD

  UC Davis Health Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Little, MS

CONTACT

916-734-7749; dalittle@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 12, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)