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

Parkinson Disease Clinical Trial

— IRIS-CLE-LRRK2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05837130
• Other study ID #: CLE-221237-001
• Status: Completed
• Phase: Early Phase 1
• Start date: July 11, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: April 2023
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Blood sample collection and an optional cerebrospinal fluid (CSF) collection
No study drug will be administered to study participants.
• Blood sample collection
No study drug will be administered to study participants.

Locations

Country	Name	City	State
France	Centre Hospitalo-Universitaire Grenoble Alpes	La Tronche
France	Centre Hospitalo-Universitaire Lille	Lille
France	Hopital La Pitié Salpétrière-Institut du Cerveau et de la Moelle Epinière-CIC Neurosciences	Paris
France	Centre Hospitalo-Universitaire Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Servier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B)		Study collection visit Day 1