Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03364894 |
Other study ID # |
NL59694.091.17 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 1, 2017 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
May 2022 |
Source |
Radboud University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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 from different types of measurements are rarely analyzed in an integrated
fashion.
Objective This study aims to create a longitudinal dataset of clinical, molecular, imaging,
and continuous wearable sensor-based data from a representative Parkinson's disease (PD)
cohort. Data will be made available to researchers worldwide to accelerate the discovery of
novel etiological insights, development of new therapeutic approaches, and personalized
disease management. For this purpose, an extensible norm for sharing research data will be
developed, meeting the latest data privacy and security standards.
Methods Supported by a multinational, public-private partnership, a prospective cohort study
was designed to include 650 representative PD patients (disease duration <5 years).
Comprehensive follow-up for at least 2 years includes: (1) annual assessment at the study
center for acquisition of detailed clinimetric data, magnetic resonance imaging, and
biospecimens (plasma, serum, cerebrospinal fluid (CSF), stool) and (2) collection of data
from the home environment, using self-assessments and an advanced wrist-worn wearable device
to continuously measure biological and environmental signals. Collection, storage, and
sharing of these research data will be facilitated by a new method to protect privacy and
enhance security using polymorphic encryption and pseudonymization (PEP), a methodology that
combines advanced encryption with distributed pseudonymization and data access management.
Conclusion This study is unique, as it includes a cohort of unbiased subjects with recently
diagnosed PD, creating an unprecedented dataset that combines longitudinally collected
clinical, molecular, imaging, and data from wearable sensors using state of the art
technology. The single-center study design minimizes measurement variability. Finally, the
innovative methodology for data privacy and protection might serve as a new international
standard for sharing research data.
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, measured at 3 time points (baseline visit, one year follow-up, and two
years' follow-up). In addition, the study protocol includes day-to-day patient monitoring
with a multisensor wearable device, the Verily Study Watch, that continuously collects data
(movement, pulse, skin temperature, ambient information) and allows for real-time data
collection between study visits. The goal of the device is to collect high-resolution,
continuous biological signals from the body. These measurements of physiology, activity, and
environmental conditions over the course of a 2-year study will be used to create a
quantified functional assessment of patients with PD. Mapping these signals with clinical
outcomes such as disease progression will allow the investigators to evaluate the
relationship between biosensor data and the clinical variables, genotypic, and imaging
biomarkers collected in the study.
This study is intended to create a unique resource of genotypic, functional, and phenotypic
data collected longitudinally on a cohort of Dutch subjects with PD (n=650), allowing the
Research Collaborators to address a series of hypothesis-driven research questions. The aim
is to develop novel etiological insights, to identify biomarkers that can assist in
predicting differences in prognosis and treatment response between patients, to improve
existing treatments, to develop new therapeutic approaches, and to develop a more precise and
personalized disease management approach.
Additionally, the cohort will serve as a source of data that can be accessed by qualified
researchers worldwide, allowing them to add their research capacity to further address the
main aims of this study. For this reason, data governance will be managed by dedicated
advisory boards and data review committees, as specified in the study protocol. Participation
in this study and results from this study will not be used for patient treatment decisions.
The aim of this study is threefold:
1. 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 magnetic resonance imaging (MRI), from cerebrospinal fluid (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 behavioral, such as
participation in exercise). Also, the investigators aim to identify biomarkers that can
assist in predicting differences in prognosis and treatment response between patients.
Finally, by developing novel etiological and pathophysiological insights, the study aims
to improve existing treatments and to develop new therapeutic approaches, as a basis for
development of a more precise and personalized disease management approach.
2. The secondary objective of the study is to evaluate the Verily Study Watch, to assess
how these devices could provide information about the function of patients with PD.
3. The tertiary objective of this study is to create an extensive longitudinal dataset
describing the genetic, clinical, functional, and phenotypic characteristics of a
representative Parkinson's disease (PD) subject cohort (n = 650) to allow researchers to
investigate important unanswered questions in PD.