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Completed

NCT Number: NCT04243304

Synaptic Density and Progression of Parkinson's Disease.

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

11C-UCB-J PET-CT

Other

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

18F-PE2I PET-MR

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2020
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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