11C-MC1 for Parkinson's (NCT04396873)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 7 years and 8 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- You will have 2-5 study visits over a period lasting 1 week to 4 months, depending on scheduling.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Intravenous infusion (minimally invasive); Injection (minimally invasive); Thinking & memory tests (non-invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.