NeuroFLiPP: Parametric PET of Neuroinflammation in Fatty Liver Disease

ConditionPositron Emission Tomography

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Davis

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Participants >=18 years age

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: ImagingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame

3 months

Secondary outcomes

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

associate the parametric PET measure of neuroinflammation (by FDG and DPA-714) with biopsy-determined liver inflammation

Time frame

3 months

Other outcomes

results from PET scans compared with Brain MRI and neurocognitive testing

correlate the PET measures with the structural measures of brain and outcome of neurocognitive testing

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov

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