The Personalized Parkinson Project
- Conditions
- Parkinson's Disease10028037
- Registration Number
- NL-OMON45667
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 650
Prior to enrollment in this clinical investigation, candidates must meet ALL of the following criteria:;* Subject has Parkinson*s disease of <=5 years duration, defined as time since diagnosis 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.
* Subject is not a current or previous employee or family member of employees of the institutions involved in the study, including Verily Life Sciences and Radboudumc.
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 Investigator.
* Contraindicated for MRI, e.g. claustrophobia, presence of an active implant, pacemaker, insulin pump, neurostimulator, ossicle prosthesis, and/or other medical device or other non-removable metal part incompatible with MRI.
* For lumbar puncture:
o Allergy to local anesthetic agents
o Medical history of compression of spinal cord, current local skin infection at the site of the lumbar puncture, developmental abnormalities in lower spine, blood coagulopathy, anticoagulant medication (Acenocoumarol, Warfarin, Dabigatran).
o Clinical (or previous MRI) evidence of structural cerebral abnormalities that are not compatible with the performance of a lumbar puncture such as malignancies, abscess, or obstructive hydrocephalus.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method