Long-term brain imaging of synapses in Parkinson's disease
Official title: Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
Run by Universitaire Ziekenhuizen KU Leuven · NCT06875765 · Data updated 2026-11-12
This project will use PET and MRI scans to see if synapse loss spreads from the brainstem to the cortex over time and whether cortical synapse loss is linked to thinking decline in people with Parkinson's disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | July 16, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | July 29, 2025 |
| Trial ID | NCT06875765 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with Parkinson's disease (and healthy controls) who participated in the earlier S61477 study and are able to undergo PET-CT and MRI scanning.
✕Probably not a fit
People who are pregnant or breastfeeding, have MRI contraindications, major unrelated neuropsychiatric or internal medical conditions, or recent excess radiation exposure are not eligible and likely will not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will re-invite people with Parkinson's disease and healthy controls who took part in an earlier longitudinal study (S61477/NCT04243304) for a follow-up visit roughly 7 years after the prior baseline (about 10 years after first motor symptoms for many participants). Participants will receive clinical motor and non-motor evaluations including cognitive testing, 11C-UCB-J PET-CT to measure the synaptic marker SV2A, 18F-FE-PE2I PET-CT to image dopamine transporter (DAT), and a brain MRI. The team will compare longitudinal changes in SV2A binding across brain regions to see whether loss begins in the brainstem and spreads to cortex, and will test whether cortical SV2A decline correlates with cognitive worsening. Standard safety and exclusion procedures apply, including contraindications to MRI and limits on recent ionizing radiation exposure.
Why it matters
Potential benefit: If successful, the findings could provide a biomarker to track synaptic loss and help predict or monitor cognitive decline in Parkinson's disease.
How similar studies have gone: Previous cross-sectional and short-term studies using SV2A PET have shown it can detect synaptic loss in neurodegenerative diseases, but long-term longitudinal data in Parkinson's disease remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participation in study S61477 (NCT04243304) Exclusion Criteria: * Neuropsychiatric diseases (unrelated to PD for PD patients) * Major internal medical diseases * History of alcohol or drug abuse * Relevant abnormalities on MR brain * Contraindications for MR * Pregnancy or breastfeeding * Previous participation in other research studies involving ionizing radiation with \> 1 mSv over past 12 months.
Where it's running
-
UZ Leuven
Leuven, Belgium Recruiting
Study contacts
- Study coordinator: Wim Vandenberghe, MD, PhD
- Email: wim.vandenberghe@uzleuven.be
- Phone: +3216344280
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.