ANCILLARY STUDY No. 3 NS-PARK-OMICS

NCT07832461 | Not Yet Recruiting DMC

• 2 other identifiers: C25-512025-A01383-46
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PARKINSON DISEASE (Disorder)

Outcome Measures

Primary Outcomes (1)

• Biomarkers associated with PD progression

  Biomarker levels measured in biological fluids

  At inclusion

Study Arms (3)

Patients

Patients from the NS-PARK cohort, carrying or not mutation in a gene known to be associated to PD

Procedure: lumbar puncture

At-risk

Individuals at-risk of developing Parkinson's disease enrolled in the NS-PARK cohort: individuals who are related to a patient with PD, unaffected carriers of a mutation in a gene known to be associated with PD, or individuals with prodromal features of the disease such as isolated REM sleep behavior disorder (RBD).

Procedure: lumbar puncture

Controls

Healthy volunteers

Procedure: lumbar puncture

Interventions

lumbar puncture PROCEDURE

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.

At-risk; Controls; Patients

Eligibility Criteria

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

Study 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.

You may qualify if:

• 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;
• Having provided written, free and informed consent to participate in this research.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Institut du Cerveau - ICM Hôpital Universitaire Pitié-Salpêtrière 47-83 Bd de l'Hôpital

Paris, 75013, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Pr Jean-Christophe CORVOL

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2033
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

FR (1)