Synaptic Density and Progression of Parkinson's Disease.

May 18, 2022 updated by: Universitaire Ziekenhuizen KU Leuven

Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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 Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD patients
At baseline and 2-year follow-up
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.
Active Comparator: Healthy controls
At baseline and 2-year follow-up
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data analysis wel be done when all subjects have undergone the baseline evaluation.
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.
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.
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.
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.
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.
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data analysis wel be done when all subjects have undergone the baseline evaluation.
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.
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.
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.
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.
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.
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Wim Vandenberghe, MD, PhD, UZ Leuven

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)

October 1, 2018

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s61477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Needs to be decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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