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Completed

NCT Number: NCT04233593

Neuroimmune Response to Lipopolysaccharide

In this study, healthy adult volunteers will undergo two positron emission tomography (PET) scans using the radiotracer [11C]PBR28 which binds to the 18kDa translocator protein (TSPO). Approximately 3 hours prior to the second [11C]PBR28 PET scan, lipopolysaccharide (LPS; endotoxin) will be administered to evoke a robust neuroimmune response. Subjects will also undergo behavioral and cognitive testing. Vital signs, subjective response, and peripheral cytokine levels will be assayed periodically throughout the experimental session.

Specific aims: Quantify the magnitude of neuroimmune response after a classical immune stimulus.

Secondary aims: Quantify changes in cognitive function after a classical immune stimulus.

Hypothesis: Individuals will exhibit a robust whole-brain neuroimmune response and impaired cognitive function after LPS.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medically-healthy male and female subjects able to read/write English

Exclusion criteria

  • Subjects cannot meet DSM criteria for substance use disorder
  • Any psychiatric symptoms that could put the subject at risk by participating in the study including but not limited to suicidal or homicidal ideation, or suicide attempt within the last year
  • Pregnancy or breastfeeding;
  • Any current medical illness that could put the subjects at risk during the PET scan, or interfere with the PET or immunologic measures
  • Significant hepatocellular injury (as evidenced by AST or ALT levels greater than 5 times normal or a history of cirrhosis) will be exclusionary in order to reduce the risks associated with alcohol consumption
  • Subjects taking corticosteroids or other immunosuppressant drugs
  • Subjects with disorders affecting the brain, including but not limited to multiple sclerosis, history of stroke, brain tumors, intracranial bleeding, infection, or abscess.

Treatment and study plan

Lipopolysaccharide

Biological

Endotoxin E Coli

Other names: LPS

Primary outcomes

  1. Baseline TSPO Availability

    Time frame: Before LPS administration (baseline)

    Time-activity curves will be extracted from brain regions of interest and analyzed using multilinear analysis-1 (t*=30) incorporating the metabolite-corrected arterial input function to yield [11C]PBR28 total volumes of distribution (VT) across brain regions.

Secondary outcomes

  1. Alcohol Dependence Scale (ADS) - questionnaire

    Time frame: baseline

    self-report questionnaire to determine severity of alcohol symptoms, 25 question multiple choice scale, range of 0-47 for a total score, with higher numbers indicating worse severity

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Imaging the Neuroimmune Response to Lipopolysaccharide

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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