ANCILLARY STUDY No. 3 NS-PARK-OMICS

ConditionPARKINSON DISEASE (Disorder)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

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

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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]).

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.

Disqualifiers

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).

Trial population

Participation in this ancillary study will be proposed to: (i) NS-PARK cohort participants who meet the selection criteria (see section above) and (ii) healthy volunteers selected from the center's active pool of volunteers.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

lumbar puncture
Procedure/Surgery
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.

Treatment groups

80 Participants

are divided into 3 treatment groups

Group A: Patients1 intervention

Group B: At-risk1 intervention

Group C: Controls1 intervention

Trial outcomes

Primary outcomes

Biomarkers associated with PD progression

Biomarker levels measured in biological fluids

Time frame

At inclusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: