French Parkinson's Disease Cohort - NS-PARK
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Affiliated to social security
Age > 10 years
Disqualifiers
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
Trial population
All patients followed at one expert center for PD or associated centers in France.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Disease progression
Hoehn and Yahr score change
Time frame
through the end of follow-up in the cohort, at least 2 years, and average of 5 years2
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
Time frame
through the end of follow-up in the cohort, at least 2 years, and average of 5 years3
Modification of antiparkinsonian treatment doses
Modification of antiparkinsonian treatment during follow-up will be measured as levodopa equivalent daily doses
Time frame
through the end of follow-up in the cohort, at least 2 years, and average of 5 yearsSecondary outcomes
1
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
Time frame
through the end of follow-up in the cohort, at least 2 years, and average of 5 years2
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.
Time frame
through the end of follow-up in the cohort, at least 2 years, and average of 5 years3
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
Time frame
through the end of follow-up in the cohort, at least 2 years, and average of 5 years4
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.
Time frame
through the end of follow-up in the cohort, at least 2 years, and average of 5 yearsSponsors and contacts
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Source ClinicalTrials.gov