Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT04233593
Status:
COMPLETED
Last Update Posted:
2022-07-19
First Post:
2020-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuroimmune Response to Lipopolysaccharide
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Imaging the Neuroimmune Response to Lipopolysaccharide
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: