The Dutch Parkinson and Cognition Study (DUPARC): A prospective study on cognitive pathology in de novo Parkinson*s disease

Recruiting

• Conditions: Parkinson; Parkinson's disease; 10028037

• Registration Number: NL-OMON50521
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 455

Inclusion Criteria

- Diagnosis Parkinson*s disease
- Disease duration < 3 months, measured after time of diagnosis.
- Willingness to cooperate and sign written informed consent

Exclusion Criteria

All subjects:
- The refusal to be informed about an unforeseen clinical finding, Exclusion
from PET:, - Pregnant or breast feeding women, Exclusion from MRI scan:, - MR
incompatible implants in the body (e.g. prosthesis, pacemakers, implanted heart
valves).
- Any risk of having metal particles in the eyes due to manual work without
proper eye protections
- Tattoos containing red pigments that form a safety risk

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints will be the change in FEOBV activity and the change in<br /><br>cognitive functioning between baseline and 3 years of follow-up. Cognitive<br /><br>functioning is measured by an extensive neuropsychological assessment, covering<br /><br>all cognitive domains.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints will be:<br /><br>- F-DOPA uptake as a measure of dopaminergic innervation.<br /><br>- Retinal evaluation using OCT technology<br /><br>- Functional connectivity using fMRI resting state<br /><br>- Neuropsychological assessment, including questionnaires<br /><br>- Systemic inflammation<br /><br>- Screening Array (GSA-MD) and/or whole-gene sequencing of the GBA1 gene.<br /><br>- GCase activity </p><br>