French Parkinson's Disease Cohort - NS-PARK (NS-PARK)

Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)

The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. A blood sampling is perform at baseline for genetic testing and implement an associated biocollection.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease

Detailed Description

The national clinical research network for Parkinson's disease (NS-PARK/FCRIN) reassembles all expert centers in Parkinson's disease (PD) in France. Its aim is to promote clinical research in Parkinson's disease and movement disorder, to better understand the pathophysiology of PD, foster the development of new therapeutic strategies, and move towards personalized medicine. To help centers for prescreening, a national registry of PD patients followed in each centers has been implemented in 2016 to collect minimal relevant clinical information of patients followed in each center including demographic data, age at diagnosis, standardized motor and non-motor symptoms evaluation, and treatment. Data are updated at each visit of the patient in the center. De facto, this registry became a longitudinal cohort of PD patients followed in NS-PARK centers. In 2020, NS-PARK received funding to associate a biocollection to this clinical cohort.

The aim of NS-PARK cohort are to describe the natural history of PD progression in clinical routine in France, to develop new models of PD describing the different progression profiles, and to propose patients stratification based on PD pathophysiological mechanisms. The cohort will also serve as a platform to discover new PD genes and genetic modifiers of disease progression or response to treatment.

• Study Type: Observational
• Enrollment (Anticipated): 30000

Contacts and Locations

• Study Contact: Name: Jean Christophe MD CORVOL, PU-PH; Phone Number: 33 1 42 16 57 66; Email: jean-christophe.corvol@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Centre 01 Paris
    • Contact: Jean Christophe MD Corvol, Pr; Phone Number: 33 1 42 16 57 66; Email: jean-christophe.corvol@aphp.fr
    • Principal Investigator: Jean Christophe MD Corvol, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients followed at one expert center for PD or associated centers in France.

Description

Inclusion Criteria:

• Diagnosis of Parkinson's disease according to UK PD brain bak criteria
• OR diagnosis of parkinsonian syndrome: multiple system atrophy, progressive supranuclear palsy, dementia with Lewy body, or corticobasal syndrom
• OR Subjects at risk of PD defined as :

No symptom or diagnosis of Parkinson's disease nor parkinsonian syndrome, and relative to a patient with a diagosis of PD or parkinsonian syndrome, or carrier of a known mutation responsible for a genetic form of PD or patient with a diagnosis of idiopathic REEM sleep disorder or prodromal form of PD as defined by MDS criteria (Berg et al., 2015)

AND for all participants

• Affiliated to social security
• Age > 10 years

Exclusion Criteria:

• Subject under legal protection
• Subject who do not consent to the research
• for the optional skin biopsy only: clinically significant coagulation abnormalities or anticoagulant treatment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	Hoehn and Yahr score change	through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Motor and non-motor complications	Occurence of motor (dyskinesia or motor fluctuations) or non-motor (dementia, dysautonomia, behavioral or psychiatric disorders, sleep disorders, falls, ...) complication	through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Modification of antiparkinsonian treatment doses	Modification of antiparkinsonian treatment during follow-up will be measured as levodopa equivalent daily doses	through the end of follow-up in the cohort, at least 2 years, and average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive factorsof PD progression: motor or non motor symptoms	Motor or non motor symptoms as measured by MDS-UPDRS scores will be used as predictive factors for primary outcomes	through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: genetic variants	Genetic variants in PD genes or the Genetic PD risk score will be used as predictive factors for primary outcomes.	through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: brain imaging markers	Brain imaging makers (iron or neuromelanine content of the substantia nigra) will be used as predictive factors for primary outcomes	through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar disease progression profiles	Clustering analyses will be performed on disease progression markers (Hoehn and Yahr score, MDS-UPDRS scores, and doses of treatment (levodopa equivalent daily doses)) to identify homogeneous groups of patients (clusters) sharing similar disease progression profiles.	through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar genetic and disease progression profiles	Co-clustering analysis of disease progression markers (Hoehn and Yahr score, MDS-UPDRS scores, and doses of treatment (levodopa equivalent daily doses)) and genetic markers (variants in PD genes or the Genetic PD risk score).	through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Genetic mutations associated with familal forms of PD	Genetic mutations will be screened by different methods (gene panels, whole exome or whole genome) in familial forms of PD. Mutations co-segregated with PD will be considered as potentially associated with the disease.	through study completion, 15 years

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Jean Christophe MD CORVOL, PU-PH, UMRS 1127

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Genetics; Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: C16-56; 2019-A01929-48 (Registry Identifier: RCB ID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No