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
Plain-Language Summary
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.