The Personalized Parkinson Project - de novo cohort

Completed

Conditions: Parkinson's Disease
10028037

Registration Number: NL-OMON49224

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 144

Inclusion Criteria

Prior to enrollment in this clinical investigation, candidates must meet ALL of
the following criteria:
* Subject has never been treated before with any symptomatic dopaminergic drug
treatment for Parkinson*s disease and is not expected to start treatment for
motor symptoms of PD within 52 weeks from baseline.
* Subject has Parkinson*s disease of <=2 years of duration, defined as the time
since the diagnosis was made by a neurologist.
* Subject is an adult, at least 18 years of age.
* Subject can read and understand Dutch.
* Subject has completed the CMO-approved Informed Consent.
* Subject is willing, competent, and able to comply with all aspects of the
protocol, including follow-up schedule and biospecimen collection.

Exclusion Criteria

Candidates must be excluded from this study if ANY of the following criteria
are met:
* Subject is pregnant or breastfeeding.
* Subject has co-morbidities that would hamper interpretation of
parkinsonian disability, such as coincident musculoskeletal abnormalities, in
the opinion of the lnvestigator.
* Subject is allergic to nickel.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Digitale biomarkers, calculated from the Verily Study Watch data, i.e.,<br /><br><br /><br>. Pulse rate<br /><br>. Skin temperature, Electrodermal activity (sweat)<br /><br>. Movement data (Accelerometer)<br /><br>. Electrocardiogram (ECG)<br /><br>. Altitude, pressure, relative humidity<br /><br>. Environment temperature<br /><br>. Ambient light level<br /><br>. Sound pressure level<br /><br><br /><br>The development of these digital biomarkers is part of the study. Selection of<br /><br>the digital biomarker is based on it's sensitivity to detect disease<br /><br>progression. </p><br>

Secondary Outcome Measures