Non-drug Treatment Study in Parkinson's Disease Patients and Healthy Volunteers to Collect Biological Samples in Order to Assess ex Vivo the Activity of Candidate Therapies and Develop Novel Analytical Methods for Biomarkers
- Conditions
- Parkinson Disease
- Interventions
- Other: Blood sample collectionOther: Blood sample collection and an optional cerebrospinal fluid (CSF) collection
- Registration Number
- NCT05837130
- Lead Sponsor
- Servier
- Brief Summary
This is a non-drug study in patients with Parkinson's Disease (PD) and healthy volunteers to process and analyze their blood and optional cerebrospinal fluid (CSF) samples ex vivo, or outside of their body, to further develop researchers knowledge on LRRK2 biomarkers. Participants were enrolled either in Cohort A or in Cohort B. A blood sample was collected in each participant within a maximum of two study visits within 14 days, and an option to complete both visits on the same day.
- Detailed Description
This study will allow researchers to assess the potency of investigational LRRK2 inhibitors, outside of participant bodies. It will enroll Parkinson's disease patients (LRRK2 G2019S symptomatic carriers and idiopathic) and healthy volunteers meeting eligibility criteria. The study will consist of a maximum of two study visits, a selection visit to check eligibility criteria, and a sample collection visit. The two visits can take place on the same day or can occur within 14 days of each other. Participants will be assigned to Cohort A or Cohort B, each include a blood sample collection, and an optional cerebrospinal fluid (CSF) collection in Cohort A. No investigational product, study drug, will be administered to study participants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Women of childbearing potential (WOCBP) must have a negative pregnancy test
- Parkinson's disease (PD) patients must be at least 40 years old
- Healthy volunteers must be at least 30 years old
- PD patients must have a PD diagnosis, according to the 2015 Movement Disorder Society criteria, with bradykinesia, and at least one of the following: muscular rigidity, or resting tremor with no other suspected cause of Parkinsonism
- The LRRK2 G2019S symptomatic carrier PD patients must have a documented G2019S mutation on the leucine-rich repeat kinase 2 gene (LRRK2)
- Pregnant or lactating women
- Have participated in an investigational drug trial within 30 days
- Are SARS-CoV-2, COVID-19, positive within 15 days prior to blood sample collection
- Have another active disease that the investigator believes could interfere with study results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort B Blood sample collection Cohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection. Cohort A Blood sample collection and an optional cerebrospinal fluid (CSF) collection Cohort A will include LRRK2 G2019S symptomatic carriers, idiopathic PD patients, and healthy volunteers. It will involve a blood sample collection and an optional cerebrospinal fluid (CSF) collection.
- Primary Outcome Measures
Name Time Method Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B) Study collection visit Day 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Hopital La Pitié Salpétrière-Institut du Cerveau et de la Moelle Epinière-CIC Neurosciences
🇫🇷Paris, France
Centre Hospitalo-Universitaire Lille
🇫🇷Lille, France
Centre Hospitalo-Universitaire Grenoble Alpes
🇫🇷La Tronche, France
Centre Hospitalo-Universitaire Toulouse
🇫🇷Toulouse, France