Status:
COMPLETED
Evaluation of a Novel PET Radioligand to Image Cyclooxygenase-1 (COX-1)
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Normal Physiology
Eligibility:
All Genders
18-99 years
Brief Summary
Background: A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is called \[11C\]PS13. This has a small amount of radioactivity that can be detected by a positron...
Detailed Description
Objective The cyclooxygenase (COX) system is implicated in the pathophysiology of brain diseases, including Alzheimer s disease and depression, and is a potential biomarker for neuroinflammation. COX...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Aged 18 years or older.
- Able to provide informed consent.
- Medically and psychiatrically healthy.
- Enrolled in 01-M-0254 The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies".
- EXCLUSION CRITERIA All phases
- Because non-steroidal anti-inflammatory drugs (NSAIDs) inhibit COX-1 and/or COX-2, subjects should not have taken NSAIDs for two weeks prior to the PET scan. In addition, aspirin must not have been taken in the prior month, as aspirin irreversibly inhibits COX.
- Clinically significant laboratory abnormalities based on tests performed under screening protocol 01-M-0254 or 17-M-0181 and specified in Section 4.c Screening.
- Any current Axis I diagnosis, based on interview and self-reporting performed under screening protocol 01-M-0254 or 17-M-0181.
- HIV infection.
- History of medical or neurologic illness or injury with the potential to affect study data interpretation.
- Recent exposure to radiation related to research (i.e. PET from other research) that, when combined with this study, would be above the allowable limits.
- Inability to lie flat on camera bed for at least two hours.
- Pregnancy or breastfeeding.
- Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not
- exclusion criteria, unless that use impairs function of daily life..
- Current use of psychiatric medications.
- NIMH employees and staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.
- EXCLUSION CRITERIA Phase 2:
- Because aspirin and celecoxib require an acidic environment to be absorbed in the stomach, we will exclude those who have taken proton pump inhibitor (PPI) drugs, H-2 receptor antagonist drugs, and antacid drugs in the last two weeks.
- additional contraindications to taking COX-1 or COX-2 inhibitors include:
- history of hypersensitivity reaction to COX inhibitors history of aspirin- or NSAID-induced asthma.
- history of upper or lower gastrointestinal bleeding, gastritis, peptic ulcer disease, or gastroesophageal reflux disease (GERD).
- coagulation disorder.
- thrombocytopenia.
- G6PD deficiency.
- history of gout.
- history of hepatic or renal impairment.
- history of cardiovascular disease or presence of cardiovascular risk factors such as hypertension.
- EXCLUSION CRITERIA Phase 3:
- Artery check for art line
- Unable to have an MRI scan
- NIH employees are eligible to participate. NIMH employee participation is guided by intramural institute policy.
Exclusion
Key Trial Info
Start Date :
October 3 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03324646
Start Date
October 3 2017
End Date
January 30 2024
Last Update
August 15 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892