NCT06875765

Long-term Longitudinal Imaging of Presynaptic Terminals in PD

Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	11C-UCB-J PET-CT	Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
OTHER	18F-PE2I PET-CT	Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I.
DIAGNOSTIC_TEST	MRI brain	Magnetic resonance imaging of brain volume.

Timeline

• Start date: 2025-07-16
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-13
• Last updated: 2025-07-29

Locations

1 site across 1 country: Belgium