ANCILLARY STUDY No. 3 NS-PARK-OMICS

N/ANot Yet RecruitingNCT07832461

Institut National de la Santé Et de la Recherche Médicale, France80 enrolled

Overview

The goal of this clinical study is to identify biomarkers associated with Parkinson's disease (PD) progression in PD patients, participants at-risk of developing PD (e.g., a person who does not have the disease but carrying a mutation known to be related to the disease or a person with a prodromal form as iRBD for example), as well as healthy volunteers. The working hypothesis of this study is that patients with Parkinson's disease can be stratified into etiological subgroups through the integration of omics data. Combining molecular signatures with longitudinal clinical and phenotypic data from the NS-PARK cohort will enable the development of disease progression models grounded in the pathophysiological mechanisms of Parkinson's disease. Researchers will compare the data with those from healthy volunteers to determine whether the findings are specific to PD, as some biomarkers may reflect broader processes related to neurodegeneration, aging, or comorbidities. In this ancillary study, in addition to the NS-PARK cohort assessments, participants will be proposed to do, during one visit: * A lumbar puncture * A blood draw * A urine collection * An olfactory test * A more detailed neuropsychological assessment

Study Type

OBSERVATIONAL

Enrollment

Conditions

PARKINSON DISEASE (Disorder)

Interventions

A 15 mL cerebrospinal fluid (CSF) sample will be collected from each participant by lumbar puncture (LP) for research purposes, after confirming the absence of any contraindications. The LP will be performed by an experienced physician, with the participant lying down. An atraumatic needle and catheter will be used to minimize the risk of post-lumbar puncture syndrome. The sample will be collected using standard equipment.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: PATIENT GROUP -Enrolled in the NS-PARK cohort in the Parkinson's disease patient group, with sample collection for genetic analysis. AT-RISK GROUP -Enrolled in the at-risk group of the NS-PARK cohort, with sample collection for genetic analysis, in accordance with the NS-PARK cohort criteria, i.e.: Individual related to a patient with Parkinson's disease; And/or * Unaffected individual carrying a mutation in a gene known to be involved in Parkinson's disease; And/or * Individual presenting a prodromal form of the disease (e.g., idiopathic REM sleep behaviour disorder \[iRBD\]). CONTROL GROUP (healthy volunteers) * Individual matched for age and sex with the patient included in this study; * No neurological disease or symptoms, as determined by the neurologist during the clinical interview, and no known history of neurological disease or symptoms. FOR ALL GROUPS * Adult individual; * Affiliated with a social security scheme or entitled to benefits under such a scheme; * Negative blood or urine pregnancy test prior to inclusion for women of childbearing potential; * Having provided written, free and informed consent to participate in this research. Exclusion Criteria: * Individuals under judicial protection (sauvegarde de justice); * Pregnant or breastfeeding women; * Individuals under guardianship or curatorship; * Known contraindication to lumbar puncture (as defined in the protocol).

ANCILLARY STUDY No. 3 NS-PARK-OMICS

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts