Synaptic Density and Progression of Parkinson's Disease.

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04243304

s61477

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

PD patients

Experimental group

Description:

At baseline and 2-year follow-up

Treatment:

Other: 11C-UCB-J PET-CT

Other: 18F-PE2I PET-MR

Healthy controls

Active Comparator group

Description:

At baseline and 2-year follow-up

Treatment:

Other: 11C-UCB-J PET-CT

Other: 18F-PE2I PET-MR