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Synaptic Density and Progression of Parkinson's Disease.

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ClinicalTrials.gov Identifier: NCT04243304
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: 11C-UCB-J PET-CT Other: 18F-PE2I PET-MR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243304


Contacts
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Contact: Wim Vandenberghe, MD, PhD +3216344280 wim.vandenberghe@uzleuven.be
Contact: Aline Delva, MD +3216345771 aline.delva@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Aline Delva, Dr.    +3216345771    aline.delva@uzleuven.be   
Sub-Investigator: Aline Delva, Dr.         
Principal Investigator: Wim Vandenberghe, Prof. Dr.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Wim Vandenberghe, MD, PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04243304    
Other Study ID Numbers: s61477
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Needs to be decided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Parkinson Disease
PET
UCB-J
PE2I
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases