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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 5 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.