PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
- Conditions
- Parkinson's DiseaseDementiaAlzheimer's DiseaseALSMild Cognitive Impairment
- Interventions
- Drug: 11C-MC1Drug: 11C-PS13Drug: 18f-florbetaben
- Registration Number
- NCT04396873
- Lead Sponsor
- National Institute of Mental Health (NIMH)
- Brief 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, or Huntington s disease 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 2-3 study visits. Participation lasts 1 week to 4 months, depending on scheduling.
- Detailed Description
Study Description:
This pilot/exploratory study will examine whether cyclooxygenase 1 (COX-1) and COX-2 are elevated in the brain of individuals with neurodegenerative brain disease compared to healthy volunteers.
Objectives:
Primary Objective: To determine whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.
Secondary Objective:
1) To determine retest variability and reliability for each radioligand. 2) To evaluate the specific binding of \[11C\]PS13 to COX-1 in healthy subjects through blocking study using Ketoprofen, a COX-1 inhibitor
Endpoints:
Primary Endpoint: Measurement of COX-1 and COX-2 density in brain after PET scans with \[11C\]PS13 and \[11C\]MC1, respectively.
Secondary endpoint: 1) To measure whole-brain distribution volume (VT) of COX-1 and COX-2 in a retest setting; 2) To correlate VT with the presence of amyloid in Alzheimer s disease (AD) patients 3) To calculate the specific binding of \[11C\]PS13 with a Lassen plot
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 168
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Only one arm 11C-MC1 All subjects receive the same tests Only one arm 11C-PS13 All subjects receive the same tests Only one arm 18f-florbetaben All subjects receive the same tests
- Primary Outcome Measures
Name Time Method Measure the concentration of radioligands 1-2 days Density of COX-1 and COX-2 in brain
- Secondary Outcome Measures
Name Time Method Measure the retest variability and reliability of the radioligans 1-2 days Density of COX-1 and COX-2 in brain
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States