NCT05837130

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

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.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Servier · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Blood sample collection and an optional cerebrospinal fluid (CSF) collection	No study drug will be administered to study participants.
OTHER	Blood sample collection	No study drug will be administered to study participants.

Timeline

• Start date: 2022-07-11
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2023-05-01
• Last updated: 2025-04-11

Locations

4 sites across 1 country: France