Evaluation of a Novel PET Radioligand to Image OGA
Completed
Conditions studied: Pharmacokinetics, Adult
In brief
Background: O-GlcNAcase (OGA) is a brain enzyme. It may play a role in brain disorders like Alzheimer s disease. Researchers want to see if a new drug can be used with positron emission tomography (PET) scans to show OGA better. Researchers want to learn more about how it acts in healthy people. Objectives: To test if the new drug \[18F\]OGA-1 can measure its receptor. To determine whether the same results occur when scanning a person twice. Eligibility: Healthy adults age 18 and older who are already enrolled in a separate protocol. Design: Some participants will have 1 whole-body PET scan during one 4-hour visit to the clinic. Some will have 2-3 brain scans (PET and MRI) over 2-3 days. For the PET scan, a needle will guide a thin plastic tube (IV catheter) into an arm vein. A small amount of radioactive chemical will be injected through the catheter. The needle will be removed. Only the catheter will be left in the vein. Another IV catheter may be placed to draw blood. Blood pressure, heart rate, and breathing rate will be measured. Participants will have an electrocardiogram. Participants will lie on a bed that slides in and out of the donut-shaped scanner. The scan will last 2-3 hours. For brain PET scan, participants will wear a plastic mask to keep their head still. For magnetic resonance imaging (MRI) scan, participants will lie on a table. The table slides in and out of the MRI scanner. This is a metal cylinder in a strong magnetic field. Participants will be in the scanner up to 1 hour.
Key facts
- Study ID
- NCT03632226
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 28
- Starts
- 2016-05-02
- Expected to finish
- 2019-06-25
- Last updated by the study team
- 2019-06-28
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Any current Axis I diagnosis, based on interview and self-reporting performed under screening protocol 01-M-0254.
- Clinically significant laboratory abnormalities, based on tests performed under screening protocol 01-M-0254 that may include: CBC, acute care panel, hepatic panel, mineral panel, UA, urine drug screen, urine HCG (females), vitamin B12, folate, lipid panel, hepatitis panel (A, B, C), RPR, total protein, hs-CRP, uric acid, CK, LDH, thyroid panel, PT/PTT, and EKG.
- Positive HIV test.
- Unable to have an MRI scan.
- History of medical or neurologic illness / 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.
- Current drug/alcohol abuse or dependence.
- NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.
- Exclusion criteria for the dosimetry subjects are the same as reported above, with the exception of MRI contraindications, because an MRI will not be performed in these subjects.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.