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NCT Number: NCT06875765

Long-term Longitudinal Imaging of Presynaptic Terminals in PD

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.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Aline Delva, MD, PhD

SUB_INVESTIGATOR

Jolien Van Opstal, MD

CONTACT

[email protected]

+16338052

Jolien Van Opstal, MD

SUB_INVESTIGATOR

Koen Van Laere, MD, MSc, PhD

SUB_INVESTIGATOR

Wim Vandenberghe, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

11C-UCB-J PET-CT

Other

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

18F-PE2I PET-CT

Other

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

MRI brain

Diagnostic Test

Magnetic resonance imaging of brain volume.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jolien Van Opstal, MD

CONTACT

[email protected]

+3216338052

Wim Vandenberghe, MD, PhD

CONTACT

[email protected]

+3216344280

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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