RecruitingPhase 1NCT04396873

PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

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


Sponsor

National Institute of Mental Health (NIMH)

Enrollment

184 participants

Start Date

Aug 17, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized PET brain scan to measure levels of enzymes called cyclooxygenases (COX-1 and COX-2), which are linked to brain inflammation, in people with neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, ALS, and other dementias. It also includes healthy volunteers for comparison. **You may be eligible if...** - You are 18 or older - You have been diagnosed by a neurologist or psychiatrist with MCI (mild cognitive impairment), ALS, Parkinson's disease, Alzheimer's disease, frontotemporal dementia, Huntington's disease, or a related condition - OR you are a healthy volunteer enrolled in specific NIH research programs - You are generally in good health aside from your neurological condition **You may NOT be eligible if...** - You have a significant abnormality in blood tests or EKG - You have taken anti-inflammatory drugs (NSAIDs) within 2 weeks of the PET scan - You have taken corticosteroids or immunosuppressants within the past month - You have a history of gastrointestinal bleeding or allergy to ketoprofen - You have another major brain disease unrelated to your primary diagnosis - You cannot lie still for at least 2 hours in the scanner - You are pregnant - You have HIV - You have substance use disorder that impairs your daily functioning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG11C-MC1

Injected IV followed by PET scanning

DRUG11C-PS13

Injected IV followed by PET scanning

DRUG18f-florbetaben

Injected IV followed by PET scanning


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04396873


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