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RECRUITING
NCT04396873
PHASE1

PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Sponsor: National Institute of Mental Health (NIMH)

View on ClinicalTrials.gov

Summary

Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation. Objective: To learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Eligibility: Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181. Design: Participants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured. Participants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs. Participants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan. Participants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.

Official title: Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2021-08-17

Completion Date

2030-10-03

Last Updated

2026-02-17

Healthy Volunteers

Yes

Interventions

DRUG

11C-MC1

Injected IV followed by PET scanning

DRUG

11C-PS13

Injected IV followed by PET scanning

DRUG

18f-florbetaben

Injected IV followed by PET scanning

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States