Neuroimmune Response to Lipopolysaccharide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-25

Study Completion Date

2021-08-17

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

All subjects will complete one 120-minute \[11C\]PBR28 PET scan before and one scan 3-hours after lipopolysaccharide (LPS; 1.0ng/kg; IV) administration. A subset of subjects will complete a follow-up \[11C\]PBR28 PET scan 24+ hours after LPS.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LPS Challenge

Subjects will undergo one 120-minute \[11C\]PBR28 PET scan before and one scan 3-hours after LPS administration (1.0ng/kg; IV).

Group Type EXPERIMENTAL

Lipopolysaccharide

Intervention Type BIOLOGICAL

Endotoxin E Coli

LPS Follow-up

Subjects will undergo one 120-minute \[11C\]PBR28 PET scan 24+ hours after LPS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lipopolysaccharide

Endotoxin E Coli

Intervention Type BIOLOGICAL

Other Intervention Names

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LPS

Eligibility Criteria

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Inclusion Criteria

1\) Medically-healthy male and female subjects able to read/write English

Exclusion Criteria

1. Subjects cannot meet DSM criteria for substance use disorder
2. 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
3. Pregnancy or breastfeeding;
4. Any current medical illness that could put the subjects at risk during the PET scan, or interfere with the PET or immunologic measures
5. 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
6. Subjects taking corticosteroids or other immunosuppressant drugs
7. Subjects with disorders affecting the brain, including but not limited to multiple sclerosis, history of stroke, brain tumors, intracranial bleeding, infection, or abscess.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes