Individual Study / Bloem et al.; BMC Neurol. 2019

The Personalized Parkinson Project: Examining Disease Progression Through Broad Biomarkers in Early Parkinson's Disease

The Personalized Parkinson Project: Examining Disease Progression Through Broad Biomarkers in Early Parkinson's Disease

Initiatives -
The primary objective of the study is to perform a set of hypothesis-driven analyses on the study data set, aiming to correlate established biomarkers (obtained clinically, from brain MRI, from CSF, from known genetic factors, and from monitoring of biosensors signals) to the rate of disease progression, and to responses to treatment (both pharmacological and behavioural, such as participation in exercise). The secondary objective of the study is to evaluate the Verily Study Watch, to assess how this device could provide information about the function of patients with Parkinson’s disease. Additionally, this cohort will serve as a source of data that can be accessed by qualified researchers worldwide. Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2017
Funding
The study is financially supported by Verily Life Sciences LLC, Radbouduniversity medical center, Radboud University, the city of Nijmegen and theProvince of Gelderland. The collaboration project is co-funded by the PPP Al-lowance made available by Health~Holland, Top Sector Life Sciences & Health,to stimulate public-private partnerships. The co-authors employed by Verily LifeSciences LCC (BRB, RK and TMS) were involved in the design of the study andpreparation of the manuscript. The other study sponsors had no role in studydesign and collection, analysis and interpretation of data or in writing the manuscript.
Visit Bloem et al.; BMC Neurol. 2019

Design

Study design
Patients' cohort
Follow Up
Participants are followed for 2 years, with three annual assessments at the study center.

Marker Paper

Bloem BR, Marks WJ Jr, Silva de Lima AL, et al. The Personalized Parkinson Project: examining disease progression through broad biomarkers in early Parkinson's disease. BMC Neurol. 2019;19(1):160. Published 2019 Jul 17. doi:10.1186/s12883-019-1394-3

PUBMED 31315608

Number of participants

Number of participants
650
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

This is a prospective, longitudinal, single-center cohort study. The cohort will comprise 650 persons with Parkinson’s disease.
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Netherlands
Ethnic Origin
Health Status
  • persons with Parkinson’s disease.
Other criteria
Parkinson’s disease duration≤5 years, defined astime since the diagnosis made by a neurologist;18 years of age or older;Able to read and understand Dutch;Willing, competent, and able to comply withall aspects of the protocol, including follow-upschedules and biospecimen collections; and providing written informed consent.

Recruitment

Sources of recruitment
  • General population

Number of participants

Number of participants
Number of participants with biosamples
Data Collection Event
Participants are asked to wear the Verily Study Watchpreferably 24/7, except during charging, for 2 years.During the baseline visit, the trial assessor discusses theimportance of ambulatory monitoring with the subjectand explains and demonstrates the use of the StudyWatch. Moreover.
Start Date
2017-10
End Date
2019-12
Data sources
  • Mobile data collection
    • Smartwatch and wearables