Synaptic Density and Progression of Parkinson's Disease.

NCT04243304 | Completed

• 1 other identifier: s61477
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; PET; UCB-J; PE2I

Outcome Measures

Primary Outcomes (4)

• Baseline differences in synaptic density.

  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.

  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.

  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.

  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 Outcomes (4)

• Baseline differences in DAT levels.

  Data analysis wel be done when all subjects have undergone the baseline evaluation.

• Correlations between clinical scores 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.

  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.

  Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

Study Arms (2)

PD patients

EXPERIMENTAL

At baseline and 2-year follow-up

Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-MR

Healthy controls

ACTIVE COMPARATOR

At baseline and 2-year follow-up

Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-MR

Interventions

11C-UCB-J PET-CT OTHER

Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

Healthy controls; PD patients

18F-PE2I PET-MR OTHER

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

Healthy controls; PD patients

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Wim Vandenberghe, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 28, 2020
• Study Start: October 1, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)