Evaluation of a Novel PET Radioligand to Image OGA

NCT03632226 | Completed FDA Drug

• 2 other identifiers: 16010516-M-0105
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetics; Adult

Keywords

PET Imaging; Neurodegeneration

Outcome Measures

Primary Outcomes (1)

• The indentifiability and time stability of the distribution volume calculated with compartmental modeling of [F18 OGA-1]. In the test-retest study the retest variability will be calculated.

  Ongoing

Secondary Outcomes (1)

• Whole-body distribution and dosimetry of [18F]OGA-1

  Ongoing

Study Arms (1)

1

Healthy Volunteers

Drug: 18F-OGA-1

Interventions

18F-OGA-1 DRUG

1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• Age greater than or equal to 18.
• Able to give written informed consent.
• Medically and psychiatrically healthy.
• Enrolled in 01-M-0254 The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers (PI: Dr. Carlos Zarate).

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 15, 2018
• Study Start: May 2, 2016
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06-25

Locations

US (1)