NCT06875765 Long-term Longitudinal Imaging of Presynaptic Terminals in PD
| NCT ID | NCT06875765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2025-07-16 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
AIM: To investigate whether SV2A loss spreads from brainstem to cerebral cortex with progression of Parkinson's disease (PD) and to determine whether longitudinal cortical SV2A loss correlates with cognitive decline in PD. STUDY DESIGN: The investigators will re-invite participants (both patients with PD and healthy controls) of a previous longitudinal study (NCT04243304, S61477) to undergo evaluation approximately 7 years after the initial baseline study visit (i.e. on average 10 years since the first motor symptoms). All participants will undergo clinical assessment of motor and non-motor symptoms (including cognitive testing), as well as 11C-UCB-J PET-CT (targeting synaptic density marker SV2A), 18F-FE-PE2I PET-CT (targeting DAT) and brain MRI.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06875765 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06875765 currently recruiting?
Yes, NCT06875765 is actively recruiting participants. Contact the research team at wim.vandenberghe@uzleuven.be for enrollment information.
Where is the NCT06875765 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06875765 clinical trial?
NCT06875765 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 35 participants.
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