French Parkinson's Disease Cohort - NS-PARK
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)
Overview
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.
Primary outcome measures
- Disease progression [Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years]
- 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]
- 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]
Secondary outcome measures (6)
- 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]
- 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]
- 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]
- 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]
- 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]
- Genetic mutations associated with familal forms of PD [Time frame: through study completion, 15 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre 01 Paris — Paris
Publications
- Lanore A, Januel E, Bertille N, Fabbri M, Mariani LL, Mangone G, Sambin S, Menon PJ, Tir M, Bereau M, Meissner WG, Thiriez C, Marques A, Remy P, Dupont G, Moro E, Defebvre L, Houeto JL, Thobois S, Azulay JP, Geny C, Frismand S, Damier P, Giordana C, Castelnovo G, Ansquer S, De Maindreville AD, Drapier S, Maltete D, Tranchant C, Rascol O, Tubach F, De Rycke Y, Corvol JC; French NS-Park Network. Mot PMID 40415148
Identifiers
NCT: NCT04888364 · C16-56 · 2019-A01929-48