Long-term brain imaging of synapses in Parkinson's disease
Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06875765 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Wim Vandenberghe, MD, PhD
- Email: wim.vandenberghe@uzleuven.be
- Phone: +3216344280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.