Map inflammation to guide treatment
- Trial ID
- NCT03457493
- Official Title
- UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy
- Goal
- Map inflammation to guide treatment
- 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 map neuroinflammation in Parkinson's by measuring activated immune cells in the brain that may contribute to disease progression. The approach uses an injected PET tracer, [18F]DPA-714, that binds the TSPO protein on activated microglia, paired with MRI and metabolite analysis to show where and how much inflammation is present; because the tracer is only for imaging it does not change or interact with levodopa or other Parkinson's medications. Adults 30 and older already enrolled in UAB's related Parkinson's immune imaging cohorts are eligible, participants must be a high or mixed TSPO binder based on rs6971 genotyping, and people with MRI/PET contraindications, low-affinity binders, or inability to safely undergo imaging are excluded. For the UDALL 5-year follow-up group you must be a UDALL baseline participant with baseline imaging done within the past 6 years.
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 map neuroinflammation in Parkinson's by measuring activated immune cells in the brain that may contribute to disease progression. The approach uses an injected PET tracer, [18F]DPA-714, that binds the TSPO protein on activated microglia, paired with MRI and metabolite analysis to show where and how much inflammation is present; because the tracer is only for imaging it does not change or interact with levodopa or other Parkinson's medications. Adults 30 and older already enrolled in UAB's related Parkinson's immune imaging cohorts are eligible, participants must be a high or mixed TSPO binder based on rs6971 genotyping, and people with MRI/PET contraindications, low-affinity binders, or inability to safely undergo imaging are excluded. For the UDALL 5-year follow-up group you must be a UDALL baseline participant with baseline imaging done within the past 6 years.
- 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?
- 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/Phase 2 trial is estimated to last approximately 10 years and 2 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.