Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
National Institute of Mental Health (NIMH)
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.
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 us…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: Patients: In order to be eligible to participate in this study, patients must meet all of the following criteria: 1. Aged 18 or older. 2. Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document. 3. Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease. 4. Be in good general health as evidenced by medical histo…
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
Location
- National Institutes of Health Clinical CenterBethesda, Maryland