11C-UCB-J PET-CT for Parkinson's (NCT06875765)
Correlate synaptic loss with cognition
- Trial ID
- NCT06875765
- Official Title
- Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
- Goal
- Correlate synaptic loss with cognition
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Study Type
- INTERVENTIONAL
- Enrollment
- 35 participants
- Conditions
- Parkinson Disease
- Interventions
- 11C-UCB-J PET-CT, 18F-PE2I PET-CT, MRI brain
Summary For Families
The goal is to follow people with Parkinson's over time to see whether loss of synapses in the brain matches and helps predict long-term cognitive decline. Participants get PET scans with 11C-UCB-J, which binds the synaptic protein SV2A to measure synaptic density, and 18F-PE2I PET to measure dopamine transporter levels in nerve terminals, plus MRI for brain structure; these are observational imaging tests that do not change medications like levodopa, they only quantify brain changes. The study is looking for adults age 30 and up who are already in study S61477, who can have MRI, are not pregnant or breastfeeding, and do not have unrelated neuropsychiatric or major medical illnesses, recent significant radiation exposure, or a history of substance abuse.
Locations
- UZ Leuven, Leuven, Belgium
Frequently Asked Questions
- What is this trial testing?
- This trial is studying 11C-UCB-J PET-CT. The goal is to follow people with Parkinson's over time to see whether loss of synapses in the brain matches and helps predict long-term cognitive decline. Participants get PET scans with 11C-UCB-J, which binds the synaptic protein SV2A to measure synaptic density, and 18F-PE2I PET to measure dopamine transporter levels in nerve terminals, plus MRI for brain structure; these are observational imaging tests that do not change medications like levodopa, they only quantify brain changes. The study is looking for adults age 30 and up who are already in study S61477, who can have MRI, are not pregnant or breastfeeding, and do not have unrelated neuropsychiatric or major medical illnesses, recent significant radiation exposure, or a history of substance abuse.
- 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 trial is estimated to last approximately 2 years and 5 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?
- You will be re-invited to undergo an evaluation approximately 7 years after the initial baseline study visit (on average 10 years since your first motor symptoms).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.