PARKINSON DISEASE (Disorder)NS-PARK-OMICSNCT07832461
ANCILLARY STUDY No. 3 NS-PARK-OMICS
An observational study of PARKINSON DISEASE (Disorder), run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- lumbar puncture
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2026to 31 Dec 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut du Cerveau - ICM Hôpital Universitaire Pitié-Salpêtrière 47-83 Bd de l'Hôpital
Paris, 75013
Pr Jean-Christophe CORVOL, +33 1 42 16 57 66, jean-christophe.corvol@aphp.fr
About this study
Official title: ANCILLARY STUDY No. 3 TO RIPH C16-56: THE NS-PARK COHORT AIMED AT IDENTIFYING BIOMARKERS FOR PARKINSON'S DISEASE
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)
- Being tested
- lumbar puncture
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar punctureProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients from the NS-PARK cohort, carrying or not mutation in a gene known to be associated to PD Receives: 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). Receives: Procedure: lumbar puncture | |
| Controls | Healthy volunteers Receives: Procedure: lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers associated with PD progression
Biomarker levels measured in biological fluids
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832461
- Sponsor's protocol ID
- C25-51
- Other IDs
- 2025-A01383-46
- Acronym
- NS-PARK-OMICS
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No