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NCT Number: NCT04888364

French Parkinson's Disease Cohort - NS-PARK

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre 01 Paris

Paris, 75013, France

Location status: Recruiting

Location contact

Jean Christophe MD Corvol, Pr

CONTACT

[email protected]

33 1 42 16 57 66

Jean Christophe MD Corvol, Pr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease progression

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    Hoehn and Yahr score change

  2. Motor and non-motor complications

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    Occurence of motor (dyskinesia or motor fluctuations) or non-motor (dementia, dysautonomia, behavioral or psychiatric disorders, sleep disorders, falls, ...) complication

  3. Modification of antiparkinsonian treatment doses

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    Modification of antiparkinsonian treatment during follow-up will be measured as levodopa equivalent daily doses

Secondary outcomes

  1. Predictive factorsof PD progression: motor or non motor symptoms

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    Motor or non motor symptoms as measured by MDS-UPDRS scores will be used as predictive factors for primary outcomes

  2. Predictive factors of PD progression: genetic variants

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    Genetic variants in PD genes or the Genetic PD risk score will be used as predictive factors for primary outcomes.

  3. Predictive factors of PD progression: brain imaging markers

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    Brain imaging makers (iron or neuromelanine content of the substantia nigra) will be used as predictive factors for primary outcomes

  4. Clusters of patients with similar disease progression profiles

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    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.

  5. Clusters of patients with similar genetic and disease progression profiles

    Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years

    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).

  6. Genetic mutations associated with familal forms of PD

    Time frame: through study completion, 15 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Christophe MD CORVOL, PU-PH

CONTACT

[email protected]

33 1 42 16 57 66

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

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

Acronym: NS-PARK

Important dates

Study start
2021
Primary completion
2028
Study completion
2030
First posted
May 17, 2021
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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