Long-term Longitudinal Imaging of Presynaptic Terminals in PD

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06875765
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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: We 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Start: 2025-07
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cross-sectional SV2A at Year 7	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Cross-sectional differences (%) in SV2A signal at Year 7 between Parkinson disease patients and controls.
Cross-sectional correlation between clinical scores and SV2A at Year 7	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Cross-sectional correlation between clinical scores and SV2A in Parkinson disease patients at Year 7.
Longitudinal SV2A change between baseline and Year 7	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Differences (%) in the rate of SV2A change between baseline and Year 7 between Parkinson disease patients and controls.
Longitudinal correlation between clinical scores and SV2A	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Correlation between progression of the clinical scores and longitudinal SV2A changes in Parkinson disease patients.

Secondary Outcome Measures

Name	Time	Method
Cross-sectional DAT levels at Year 7	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Cross-sectional differences (%) in DAT levels at Year 7 between Parkinson disease patients and controls.
Cross-sectional correlation between clinical scores and DAT levels at Year 7	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Cross-sectional correlation between clinical scores and DAT levels in Parkinson disease patients at Year 7.
Longitudinal DAT level change between baseline and Year 7	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Differences (%) in the rate of DAT level change between baseline and Year 7 between Parkinson disease patients and controls.
Longitudinal correlation between clinical scores and DAT levels	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Correlation between progression of the clinical scores and longitudinal DAT level changes in Parkinson disease patients.
Longitudinal correlation between SV2A and DAT levels	Data analysis will be done when all subjects have undergone Year 7 evaluation.	Correlation between SV2A changes and DAT level changes in Parkinson disease patients.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium