Image brain cyclooxygenase related inflammation

Trial ID
NCT04396873
Official Title
Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Goal
Image brain cyclooxygenase related inflammation
Phase
PHASE1
Status
RECRUITING
Sponsor
National Institute of Mental Health (NIMH)
Study Type
INTERVENTIONAL
Enrollment
184 participants
Conditions
Parkinson's Disease, Dementia, Alzheimer's Disease, ALS, Mild Cognitive Impairment
Interventions
11C-MC1, 11C-PS13, 18f-florbetaben

Plain-Language Summary

The goal is to map cyclooxygenase enzymes in the brain to better understand neuroinflammation across Parkinson's, Alzheimer's, ALS, mild cognitive impairment, and related dementias, which may help explain differences between conditions and guide future therapies. The approach uses PET scans with two radiotracers that bind COX enzymes to visualize inflammatory enzyme activity, plus 18F-florbetaben to image amyloid plaques; these scans are diagnostic only, do not treat disease or change Parkinson's drugs like levodopa, and you must avoid NSAIDs and some other anti-inflammatory drugs beforehand because they can block tracer binding. Adults 18 and older are being enrolled, including people diagnosed by a neurologist or psychiatrist with PD, MCI, ALS, or other adult-onset dementias and healthy volunteers who can consent and travel to NIH, with exclusions for pregnancy, HIV, certain medical problems or implants, recent conflicting research radiation, inability to lie still, and recent use of disallowed medications.

Locations

  • National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Frequently Asked Questions

What is this trial testing?
This trial is studying 11C-MC1. The goal is to map cyclooxygenase enzymes in the brain to better understand neuroinflammation across Parkinson's, Alzheimer's, ALS, mild cognitive impairment, and related dementias, which may help explain differences between conditions and guide future therapies. The approach uses PET scans with two radiotracers that bind COX enzymes to visualize inflammatory enzyme activity, plus 18F-florbetaben to image amyloid plaques; these scans are diagnostic only, do not treat disease or change Parkinson's drugs like levodopa, and you must avoid NSAIDs and some other anti-inflammatory drugs beforehand because they can block tracer binding. Adults 18 and older are being enrolled, including people diagnosed by a neurologist or psychiatrist with PD, MCI, ALS, or other adult-onset dementias and healthy volunteers who can consent and travel to NIH, with exclusions for pregnancy, HIV, certain medical problems or implants, recent conflicting research radiation, inability to lie still, and recent use of disallowed medications.
Who can participate?
Participants must be between 18 Years and 99 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This Phase 1 trial is estimated to last approximately 7 years and 8 months.

View on ClinicalTrials.gov