Clinical trial NCT04888364: French Parkinson's Disease Cohort - NS-PARK
Official title: Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Genetics
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2021-05-17
Enrollment: 30000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients followed at one expert center for PD or associated centers in France.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease progression
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
measure: Motor and non-motor complications
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
measure: Modification of antiparkinsonian treatment doses
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Secondary outcomes:
measure: Predictive factorsof PD progression: motor or non motor symptoms
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
measure: Predictive factors of PD progression: genetic variants
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
measure: Predictive factors of PD progression: brain imaging markers
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
measure: Clusters of patients with similar disease progression profiles
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
measure: Clusters of patients with similar genetic and disease progression profiles
timeFrame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
measure: Genetic mutations associated with familal forms of PD
timeFrame: through study completion, 15 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre 01 Paris
Study officials:
affiliation: UMRS 1127
name: Jean Christophe MD CORVOL, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: