Institut du Cerveau - ICM Hôpital Universitaire Pitié-Salpêtrière 47-83 Bd de l'Hôpital
Paris, 75013, France
NCT Number: NCT07832461
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
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Paris, 75013, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
CONTROL GROUP (healthy volunteers)
FOR ALL GROUPS
Exclusion criteria
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.
Time frame: At inclusion
Biomarker levels measured in biological fluids
Contact information is provided by the study sponsor or research team.
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
ANCILLARY STUDY No. 3 TO RIPH C16-56: THE NS-PARK COHORT AIMED AT IDENTIFYING BIOMARKERS FOR PARKINSON'S DISEASE
Acronym: NS-PARK-OMICS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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