DPA-714-PET/MRI for Parkinson's (NCT03457493)
Link brain inflammation to symptoms
- Trial ID
- NCT03457493
- Official Title
- UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy
- Goal
- Link brain inflammation to symptoms
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- INTERVENTIONAL
- Enrollment
- 205 participants
- Conditions
- Parkinson Disease
- Interventions
- DPA-714-PET/MRI, 5-year Follow-up DPA-714-PET/MRI, DPA-714 Metabolite Analysis
Summary For Families
The goal is to find out whether people with Parkinson's have more brain inflammation than healthy people, and whether that inflammation links to symptoms and to blood and spinal fluid measures collected in related UAB studies. The approach uses a small radioactive tracer called DPA-714 with positron emission tomography and magnetic resonance imaging to make a non-invasive map of brain inflammation; DPA-714 binds to a protein called TSPO that is higher in activated brain immune cells, and the scans will be compared with clinical and biosample data. The study plans to enroll 100 people with Parkinson's and 100 healthy volunteers for baseline scans, rescans about five years later in 67 of the Parkinson's group, and a small group of five people for extra blood sampling to check tracer metabolism. To join, people must be at least 30, already enrolled in the linked UAB Parkinson's immunity studies, have the right TSPO genetic type (not a low binder), be able to undergo PET and MRI scans, and women of childbearing potential need a recent negative pregnancy test.
Locations
- UAB Advanced Imaging Facility, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DPA-714-PET/MRI. The goal is to find out whether people with Parkinson's have more brain inflammation than healthy people, and whether that inflammation links to symptoms and to blood and spinal fluid measures collected in related UAB studies. The approach uses a small radioactive tracer called DPA-714 with positron emission tomography and magnetic resonance imaging to make a non-invasive map of brain inflammation; DPA-714 binds to a protein called TSPO that is higher in activated brain immune cells, and the scans will be compared with clinical and biosample data. The study plans to enroll 100 people with Parkinson's and 100 healthy volunteers for baseline scans, rescans about five years later in 67 of the Parkinson's group, and a small group of five people for extra blood sampling to check tracer metabolism. To join, people must be at least 30, already enrolled in the linked UAB Parkinson's immunity studies, have the right TSPO genetic type (not a low binder), be able to undergo PET and MRI scans, and women of childbearing potential need a recent negative pregnancy test.
- Who can participate?
- Participants must be at least 30 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/Phase 2 trial is estimated to last approximately 10 years and 2 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?
- Baseline cohort participants will have one one-time DPA-714 PET/MRI imaging; 5-year follow-up cohort participants will have one follow-up DPA-714 PET/MRI imaging approximately 5 years after baseline; metabolite cohort participants will have one one-time DPA-714 PET/MRI imaging with arterial line placement and metabolite sampling.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.