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Completed

NCT Number: 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

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.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Centre Hospitalo-Universitaire Grenoble Alpes, La Tronche, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample collection and an optional cerebrospinal fluid (CSF) collection

Other

No study drug will be administered to study participants.

Blood Sample Collection

Other

No study drug will be administered to study participants.

Primary outcomes

  1. Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B)

    Time frame: Study collection visit Day 1

Sponsors and collaborators

Lead sponsor

Servier

Industry

Registry information

Official study 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.

Acronym: IRIS-CLE-LRRK2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 1, 2023
Registry last updated
Apr 11, 2025

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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