[18F]PI-2620 for Parkinson's (NCT07020026)
Measure brain tau protein buildup
- 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
- Measure brain tau protein buildup
- 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 measure how much tau protein builds up in the brains of people with ordinary Parkinson's disease and Parkinson's linked to LRRK2, and to compare that level to people with progressive supranuclear palsy, corticobasal syndrome, and healthy volunteers. The approach is to use a tau-targeting positron emission tomography scan with the tracer [18F]PI-2620 and a high-resolution camera called NeuroEXPLORER to see where the tracer binds; some first-year participants may be scanned on both the new and a standard PET camera and those scanned in year one will have a repeat scan at 12 months to track change. The study is enrolling adults age 45 to 85 who can give consent, with Parkinson's patients and healthy controls drawn from the PPMI study and additional people who meet the diagnosis rules for progressive supranuclear palsy or corticobasal syndrome.
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 measure how much tau protein builds up in the brains of people with ordinary Parkinson's disease and Parkinson's linked to LRRK2, and to compare that level to people with progressive supranuclear palsy, corticobasal syndrome, and healthy volunteers. The approach is to use a tau-targeting positron emission tomography scan with the tracer [18F]PI-2620 and a high-resolution camera called NeuroEXPLORER to see where the tracer binds; some first-year participants may be scanned on both the new and a standard PET camera and those scanned in year one will have a repeat scan at 12 months to track change. The study is enrolling adults age 45 to 85 who can give consent, with Parkinson's patients and healthy controls drawn from the PPMI study and additional people who meet the diagnosis rules for progressive supranuclear palsy or corticobasal syndrome.
- 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?
- 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 2 trial is estimated to last approximately 1 year and 11 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- The study is planned to be conducted over a period of two years.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive). Confirm the full schedule with the study coordinator.