Long-term Longitudinal Imaging of Presynaptic Terminals in PD

July 25, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Wim Vandenberghe, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Koen Van Laere, MD, MSc, PhD
        • Sub-Investigator:
          • Aline Delva, MD, PhD
        • Sub-Investigator:
          • Jolien Van Opstal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy controls
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.
Experimental: Parkinson disease patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-sectional SV2A at Year 7
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional correlation between clinical scores and SV2A at Year 7
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal SV2A change between baseline and Year 7
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between clinical scores and SV2A
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-sectional DAT levels at Year 7
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional correlation between clinical scores and DAT levels at Year 7
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal DAT level change between baseline and Year 7
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between clinical scores and DAT levels
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between SV2A and DAT levels
Time Frame: 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.
Data analysis will be done when all subjects have undergone Year 7 evaluation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S69680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe