Profiling Parkinson's disease

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1515

Inclusion Criteria

Prior to enrollment in this clinical investigation, candidates must meet ALL of
the following criteria:
Patients:
• recently diagnosed with PD (N=625; time since Parkinson diagnosis <= 2 years)
or not recently diagnosed with PD (N=625; time since Parkinson diagnosis >2 &
<=15 years) (Time since Parkinson diagnosis (in years) made by a neurologist; In
order to obtain a good representation of the PD population an even distribution
with respect to gender and age (age categories: <55 years, 55-65 years and >65
years) in both patient groups, will be attempted.
• 18 years or older;
• able to read and speak Dutch
• Providing IRB-approved Informed Consent;
• Willing, competent and able to comply with all aspects of the protocol,
including follow-up schedule and biospecimen collections.

Controls:
• 18 years or older
• Healthy (Self-report)
• Is able to read and speak Dutch
• Even distribution with respect to gender and age of the patient groups will
be attempted
• Providing IRB-approved Informed Consent;
• Willing, competent and able to comply with all aspects of the protocol,
including follow-up schedule and biospecimen collections.

Exclusion Criteria

Patients
• Patients who received brain surgery for Parkinson*s disease, patients who
currently use levodopa continuous intestinal gel or patients who are currently
receiving apomorphine treatment.
• presence of co-morbidities that would hamper interpretation of parkinsonian
disability, in the opinion of the lnvestigator.
• MoCa score of <=16 (indicates dementia)
• Unwillingness to be informed of unexpected medical findings
• Note: patients with a disease duration of <=2 yrs, are excluded if:
- Current, recent or past participant in The Personalized Parkinson
Project (*de Parkinson op
maat studie*) from Radboudumc.
• Patients with a disease duration of > 2 & <= 15 yrs, are only excluded if they
are currently a participant in The Personalized Parkinson
Project (*de Parkinson op maat studie*) from Radboudumc.

Controls
• A history of neurological disorders that affect the brain or central nervous
system
• Abnormal findings at general neurological examination
• Unwillingness to be informed of unexpected medical findings

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>main study parameters are biomarker concentrations (i.e. blood, CSF & feces),<br /><br>skin alpha-synuclein (a-syn) aggregation, ADR occurrence and cognition scores.</p><br>

Secondary Outcome Measures