Synaptic Density and Progression of Parkinson's Disease.
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
11C-UCB-J PET-CT
18F-PE2I PET-MR
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson Disease, PET, UCB-J, PE2I
Eligibility Criteria
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.
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PD patients
Healthy controls
Arm Description
At baseline and 2-year follow-up
At baseline and 2-year follow-up
Outcomes
Primary Outcome Measures
Baseline differences in synaptic density.
Baseline differences (%) in synaptic density between patients and controls.
Correlations between clinical scores and synaptic density.
Correlations between clinical scores and synaptic density in the patient group.
Differences in the rate of decline of synaptic density.
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.
Correlations between progression of the clinical scores and decline of synaptic density in the patient group.
Secondary Outcome Measures
Baseline differences in DAT levels.
Baseline differences (%) in DAT levels between patients and controls.
Correlations between clinical scores and DAT levels.
Correlations between clinical scores and DAT levels in the patient group.
Differences in the rate of decline of global and DAT levels.
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.
Correlations between progression of the clinical scores and decline of DAT levels in the patient group.
Full Information
NCT ID
NCT04243304
First Posted
January 10, 2020
Last Updated
May 18, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04243304
Brief Title
Synaptic Density and Progression of Parkinson's Disease.
Official Title
Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, PET, UCB-J, PE2I
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal study design (2 years follow up) where results of SV2A PET/CT, PE2I PET/MR and clinical rating scales are compared between PD patients and healthy controls.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD patients
Arm Type
Experimental
Arm Description
At baseline and 2-year follow-up
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
At baseline and 2-year follow-up
Intervention Type
Other
Intervention Name(s)
11C-UCB-J PET-CT
Intervention Description
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
Intervention Type
Other
Intervention Name(s)
18F-PE2I PET-MR
Intervention Description
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
Primary Outcome Measure Information:
Title
Baseline differences in synaptic density.
Description
Baseline differences (%) in synaptic density between patients and controls.
Time Frame
Data analysis wel be done when all subjects have undergone the baseline evaluation.
Title
Correlations between clinical scores and synaptic density.
Description
Correlations between clinical scores and synaptic density in the patient group.
Time Frame
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Title
Differences in the rate of decline of synaptic density.
Description
Differences (%) in the rate of decline of synaptic density between patients and controls.
Time Frame
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Title
Correlations between progression of the clinical scores and decline of synaptic density.
Description
Correlations between progression of the clinical scores and decline of synaptic density in the patient group.
Time Frame
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary Outcome Measure Information:
Title
Baseline differences in DAT levels.
Description
Baseline differences (%) in DAT levels between patients and controls.
Time Frame
Data analysis wel be done when all subjects have undergone the baseline evaluation.
Title
Correlations between clinical scores and DAT levels.
Description
Correlations between clinical scores and DAT levels in the patient group.
Time Frame
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Title
Differences in the rate of decline of global and DAT levels.
Description
Differences (%) in the rate of decline of global and DAT levels between patients and controls.
Time Frame
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Title
Correlations between progression of the clinical scores and decline of DAT levels.
Description
Correlations between progression of the clinical scores and decline of DAT levels in the patient group.
Time Frame
Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Vandenberghe, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Needs to be decided.
Learn more about this trial
Synaptic Density and Progression of Parkinson's Disease.
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