Recruiting
Early Phase 1

Liver-Brain Imaging

Sponsor:

UCLA

Code:

NCT06453915

Conditions

Positron Emission Tomography

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-DPA-714

18F-FDG

Study Details

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

Study ID

NCT06453915

Start date

Apr 30, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

18F-DPA-714

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

18F-FDG

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

Primary outcome measure

  • results of 18F-FDG scans compared with results of DPA-714 scans [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Dana Little, MS

916-734-7749dalittle@ucdavis.edu

Locations

UC Davis EXPLORER Molecular Imaging Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Dana Little, MS

916-734-7749dalittle@ucdavis.edu

Principal Investigator:

Guobao Wang, PhD

More Information

Sponsor

University of California, Davis

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-08-18.