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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.