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Recruiting NCT06875765

Long-term Longitudinal Imaging of Presynaptic Terminals in PD

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 11C-UCB-J PET-CT, 18F-PE2I PET-CT, MRI brain.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Cross-sectional 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 at Year 7 [Time frame: 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.]
  • Longitudinal correlation between clinical scores and SV2A [Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.]
Secondary outcome measures (5)
  • Cross-sectional 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 at Year 7 [Time frame: 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.]
  • Longitudinal correlation between clinical scores and DAT levels [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Publications

  • 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
  • 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

Identifiers

NCT: NCT06875765 · S69680

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗