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NCT03632226
Evaluation of a Novel PET Radioligand to Image OGA
trial testing 18F-OGA-1 in Pharmacokinetics in 28 participants. Completed in 25 June 2019.
25 June 2019
Quick facts
| Lead sponsor | National Institute of Mental Health (NIMH) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 28 |
| Start date | 2 May 2016 |
| Primary completion | 25 June 2019 |
| Estimated completion | 25 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 18F-OGA-1 — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
- Adult — all drugs for Adult →
Sponsor
National Institute of Mental Health (NIMH)
Who can join
Adults 18 to 100, any sex, with Pharmacokinetics or Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
PET ligands [<sup>18</sup>F]LSN3316612 and [<sup>11</sup>C]LSN3316612 quantify <i>O</i>-linked-β-<i>N</i>-acetyl-glucosamine hydrolase in the brain.
Lu S, Haskali MB, Ruley KM, Dreyfus NJ, et al · · 2020 · cited 24× · PMID 32404505 · DOI 10.1126/scitranslmed.aau2939 -
Region- and voxel-based quantification in human brain of [<sup>18</sup>F]LSN3316612, a radioligand for O-GlcNAcase.
Lee JH, Veronese M, Liow JS, Morse CL, et al · · 2021 · cited 4× · PMID 33796956 · DOI 10.1186/s13550-021-00780-z
Verify or expand the search:
- PubMed search for NCT03632226
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03632226 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Mental Health (NIMH)
- Last refreshed: 28 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03632226.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing