French Parkinson's Disease Cohort - NS-PARK

NCT04888364 | Recruiting

• 2 other identifiers: C16-562019-A01929-48
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Genetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Predictive factorsof PD progression: motor or non motor symptoms

  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

  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

  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

  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

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

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Centre 01 Paris

Paris, 75013, France

RECRUITING

Related Publications (1)

• 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. Motor and Non-motor Complications Following Different Early Therapies in Parkinson's Disease: Longitudinal Analysis of Real-Life Clinical and Therapeutic Data from the French NS-PARK Cohort. CNS Drugs. 2025 Sep;39(9):879-891. doi: 10.1007/s40263-025-01193-5. Epub 2025 May 25.

  PMID: 40415148 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biosampling is optional and includes: * biosamples specifically collected for this research: blood samples (for DNA extraction and storage, peripheral white blood cells, and plasma); skin biopsy for isolation, culture and storage of fibroblasts; urine; saliva; * biosamples collected in clinical routine, part of it being stored for research purposes: CSF, salivari accessory gland biopsies.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean Christophe MD CORVOL, PU-PH

  UMRS 1127

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Christophe MD CORVOL, PU-PH

CONTACT

33 1 42 16 57 66; jean-christophe.corvol@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 17, 2021
• Study Start: June 16, 2021
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

FR (1)