Clinical trial NCT04243304: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
PET
UCB-J
PE2I
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Baseline differences in synaptic density.
timeFrame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
measure: Correlations between clinical scores and synaptic density.
timeFrame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
measure: Differences in the rate of decline of synaptic density.
timeFrame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
measure: Correlations between progression of the clinical scores and decline of synaptic density.
timeFrame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary outcomes:
measure: Baseline differences in DAT levels.
timeFrame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
measure: Correlations between clinical scores and DAT levels.
timeFrame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
measure: Differences in the rate of decline of global and DAT levels.
timeFrame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
measure: Correlations between progression of the clinical scores and decline of DAT levels.
timeFrame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Wim Vandenberghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: