PET Imaging of Cyclooxygenases in Dementia
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- STATUS
- Recruiting
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- participants needed
- 64
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- sponsor
- 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 if two new radiolabeled drugs, [11C]PS13 and [11C]MC1, can measure inflammation in the brain using positron emission tomography (PET) imaging.
- Eligibility
Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, 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 neurological exam and 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.
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 dementia compared to healthy volunteers.
Objectives: Primary Objective: To determine whether COX-1 or COX-2 is elevated in the brains of individuals with dementia compared to healthy volunteers.
Endpoints: Primary Endpoint: Measurement of COX-1 and COX-2 density in brain after PET scans with [11C]PS13 and [11C]MC1, respectively.
Study Population: Four groups of 16 subjects each will be studied: 1) Alzheimer s disease (AD), 2) frontotemporal dementia (FTD) 3) other dementias, and 4) healthy volunteers. Subjects may be male or female. They must be greater than or equal to 18 years old, but most are expected to be 60 to 80 years old. Subjects may be recruited from anywhere, but most are expected to come from the Washington DC metropolitan area. Patients must be in good medical health but may be unable to provide informed consent because of cognitive impairment. In that case, the Legally Appointed Representative (LAR) must provide consent, and the patient must provide assent.
Phase: 1
Description of Sites/Facilities Enrolling Participants: Screening and PET imaging will be performed at the NIH Clinical Center.
Description of Study Intervention:
Subjects will be intravenously injected with 20 mCi of each of two radioligands: [11C]MC1 and [11C]PS13. Subjects will also have a radial artery catheter(s) inserted to measure the concentration of radioligand (either one insertion (if both scans are performed on the same day) or two insertions (if the scans are performed on two different days). Subjects will also have a brain MRI to provide anatomic orientation for the PET scans.
Study Duration: 36 months
Participant Duration: One week to four months, depending on the patient s availability and access to MRI and PET cameras.
Details
| Condition | Dementia, Dementia, Alzheimer's Disease, Alzheimer's Disease |
|---|---|
| Age | 18-100 years |
| Treatment | 11C-MC1, 11C-PS13 |
| Clinical Study Identifier | NCT04396873 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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