Synaptic Density and Progression of Parkinson’s Disease.

Overview

AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD. DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.

Full Title of Study: “Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson’s Disease.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2022

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-MR
    • Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.

Arms, Groups and Cohorts

  • Experimental: PD patients
    • At baseline and 2-year follow-up
  • Active Comparator: Healthy controls
    • At baseline and 2-year follow-up

Clinical Trial Outcome Measures

Primary Measures

  • Baseline differences in synaptic density.
    • Time Frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
    • Baseline differences (%) in synaptic density between patients and controls.
  • Correlations between clinical scores and synaptic density.
    • Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
    • Correlations between clinical scores and synaptic density in the patient group.
  • Differences in the rate of decline of synaptic density.
    • Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
    • Differences (%) in the rate of decline of synaptic density between patients and controls.
  • Correlations between progression of the clinical scores and decline of synaptic density.
    • Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
    • Correlations between progression of the clinical scores and decline of synaptic density in the patient group.

Secondary Measures

  • Baseline differences in DAT levels.
    • Time Frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
    • Baseline differences (%) in DAT levels between patients and controls.
  • Correlations between clinical scores and DAT levels.
    • Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
    • Correlations between clinical scores and DAT levels in the patient group.
  • Differences in the rate of decline of global and DAT levels.
    • Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
    • Differences (%) in the rate of decline of global and DAT levels between patients and controls.
  • Correlations between progression of the clinical scores and decline of DAT levels.
    • Time Frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
    • Correlations between progression of the clinical scores and decline of DAT levels in the patient group.

Participating in This Clinical Trial

Inclusion Criteria

  • PD diagnosis based on MDS clinical diagnostic criteria for Parkinson's disease – Less than 5 years disease duration since motor symptom onset according to the patient – Hoehn-Yahr stage 1 or 2 in medication ON state – Capacity to understand the informed consent form Exclusion Criteria:

  • Neuropsychiatric diseases other than PD – Major internal medical diseases – Relevant abnormalities on MR brain – History of alcohol or drug abuse – Contraindications for MR – Pregnancy – Previous participation in other research studies involving ionizing radiation with > 1 mSv over past 12 months.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wim Vandenberghe, MD, PhD, Principal Investigator, UZ Leuven

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