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Synaptic Density and Progression of Parkinson's Disease.

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04243304
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
40.9
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 11C-UCB-J PET-CT
  • Other: 18F-PE2I PET-MR
 N/A

Study Design

Study Type:
Interventional
Actual 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.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 :
Oct 1, 2018
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Baseline differences in synaptic density. [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. [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. [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. [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. [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. [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. [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04243304
Other Study ID Numbers:
  • s61477
First Posted:
Jan 28, 2020
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Parkinson Disease

Study Results

No Results Posted as of May 19, 2022