Long-term Longitudinal Imaging of Presynaptic Terminals in PD

NCT06875765 | Recruiting

• 1 other identifier: S69680
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; PET; UCB-J; PE2I; Positron Emission Tomography

Outcome Measures

Primary Outcomes (4)

• Cross-sectional SV2A at Year 7

  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

  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

  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

  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 Outcomes (5)

• Cross-sectional 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 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

  Data analysis will be done when all subjects have undergone Year 7 evaluation.

• Longitudinal correlation between clinical scores and DAT levels

  Data analysis will be done when all subjects have undergone Year 7 evaluation.

• Longitudinal correlation between SV2A and DAT levels

  Data analysis will be done when all subjects have undergone Year 7 evaluation.

Study Arms (2)

Parkinson disease patients

EXPERIMENTAL

Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-CT; Diagnostic Test: MRI brain

Healthy controls

ACTIVE COMPARATOR

Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-CT; Diagnostic Test: MRI brain

Interventions

11C-UCB-J PET-CT OTHER

Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

Healthy controls; Parkinson disease patients

18F-PE2I PET-CT OTHER

Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I.

Healthy controls; Parkinson disease patients

MRI brain DIAGNOSTIC_TEST

Magnetic resonance imaging of brain volume.

Healthy controls; Parkinson disease patients

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in study S61477 (NCT04243304)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (2)

• Delva A, Van Weehaeghe D, Koole M, Van Laere K, Vandenberghe W. Loss of Presynaptic Terminal Integrity in the Substantia Nigra in Early Parkinson's Disease. Mov Disord. 2020 Nov;35(11):1977-1986. doi: 10.1002/mds.28216. Epub 2020 Aug 7.

  PMID: 32767618 BACKGROUND

• Delva A, Van Laere K, Vandenberghe W. Longitudinal Positron Emission Tomography Imaging of Presynaptic Terminals in Early Parkinson's Disease. Mov Disord. 2022 Sep;37(9):1883-1892. doi: 10.1002/mds.29148. Epub 2022 Jul 12.

  PMID: 35819412 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Wim Vandenberghe, MD, PhD

CONTACT

+3216344280; wim.vandenberghe@uzleuven.be

Jolien Van Opstal, MD

CONTACT

+3216338052; jolien.vanopstal@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal study design (total follow up time of 7 years) where longitudinal changes of SV2A PET, PE2I PET and clinical rating scales will be compared between patients with PD and healthy controls.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)