Status:
ACTIVE_NOT_RECRUITING
The Personalized Parkinson Project (PPP)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Verily Life Sciences LLC
University Medical Center Groningen
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Brief Summary
Background Our understanding of PD has stagnated, partly due to the limited patient diversity and brief followup captured in most study cohorts. Additionally, potentially valuable biomarkers derived f...
Detailed Description
The Personalized Parkinson Project proposes an unbiased approach to biomarker development with multiple clinical, genomic and other molecular, and imaging biomarkers measured in a large population, me...
Eligibility Criteria
Inclusion
- 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 Informed Consent form, as approved by the Ethics Committee.
- 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 employee or family member of employees of the institutions involved in the study.
Exclusion
- Subject is pregnant or breastfeeding.
- Subject is allergic to nickel.
- 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:
- Allergy to local anesthetic agents
- 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).
- 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.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2028
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT03364894
Start Date
October 1 2017
End Date
March 31 2028
Last Update
March 24 2025
Active Locations (1)
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1
Radboud university medical center
Nijmegen, Netherlands, 6500 HB