Synaptic Density and Progression of Parkinson's Disease.

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243304
• Other study ID #: s61477
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• 11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
• 18F-PE2I PET-MR
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Baseline differences in DAT levels.	Baseline differences (%) in DAT levels between patients and controls.	Data analysis wel be done when all subjects have undergone the baseline evaluation.
Secondary	Correlations between clinical scores and DAT levels.	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.
Secondary	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.	Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary	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.	Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.