Brain imaging maps protein clumps
- Trial ID
- NCT07020026
- Official Title
- Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease Using [18F]PI-2620: A High-resolution PET Imaging Study Using NeuroEXPLORER (NX PI-2160 in PD)
- Goal
- Brain imaging maps protein clumps
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson's Disease
- Interventions
- [18F]PI-2620
Summary For Families
The goal is to map where tau protein builds up in people with sporadic and LRRK2 Parkinson's disease, and compare that to controls and other parkinsonian syndromes to see how tau relates to symptoms and blood or CSF biomarkers. The approach uses a high-resolution NeuroEXPLORER PET scan with [18F]PI-2620, a radioactive tracer that binds aggregated tau so affected brain regions light up on imaging; it is a diagnostic scan, not a treatment, so it does not change levodopa or other Parkinson's medications. The trial is enrolling adults 45 to 85 years old, mainly participants already in the PPMI study as sporadic or LRRK2 PD, plus PPMI healthy controls and people with PSP or CBS who meet clinical and DaTscan criteria. Participants must be able to consent, have known CSF alpha-synuclein seeding and plasma pTau217 status if in the PD groups, and women of childbearing potential must have negative pregnancy tests and use effective contraception.
Locations
- Institute for Neurodegenerative Disorders / XingImaging, LLC, New Haven, Connecticut, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [18F]PI-2620. The goal is to map where tau protein builds up in people with sporadic and LRRK2 Parkinson's disease, and compare that to controls and other parkinsonian syndromes to see how tau relates to symptoms and blood or CSF biomarkers. The approach uses a high-resolution NeuroEXPLORER PET scan with [18F]PI-2620, a radioactive tracer that binds aggregated tau so affected brain regions light up on imaging; it is a diagnostic scan, not a treatment, so it does not change levodopa or other Parkinson's medications. The trial is enrolling adults 45 to 85 years old, mainly participants already in the PPMI study as sporadic or LRRK2 PD, plus PPMI healthy controls and people with PSP or CBS who meet clinical and DaTscan criteria. Participants must be able to consent, have known CSF alpha-synuclein seeding and plasma pTau217 status if in the PD groups, and women of childbearing potential must have negative pregnancy tests and use effective contraception.
- Who can participate?
- Participants must be between 45 Years and 85 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 2 trial is estimated to last approximately 1 year and 11 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.