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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 (IRIS-CLE-LRRK2)
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How to participate to the study?
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 4 locations
Study 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.
Official title: An Open-label, Phase 0 Clinical Study in Parkinson's Disease Patients and Healthy Volunteers for the Establishment of Biomarker Analytical Methods and ex Vivo Assessment of the Potency of LRRK2 Inhibitors Using Human Biological Samples.
Conditions
Parkinson Disease
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Blood sample collection and an optional cerebrospinal fluid (CSF) collection
- Blood sample collection
Other study id numbers
Other identification numbers the study may be known by.
- CLE-221237-001
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
30 years to 85 years
(Adult, Older Adult)
Sexes
Male/FemaleAccepts Healthy Volunteers
Yes- * 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
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Cohort A
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.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Other:
Blood sample collection and an optional cerebrospinal fluid (CSF) collection
No study drug will be administered to study participants.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Cohort B
Cohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Other:
Blood sample collection
No study drug will be administered to study participants.
Keywords
Additional Relevant MeSH Terms Glioma
Parkinson Disease