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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2022-11-29

Brief Summary

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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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Detailed Description

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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

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Analysis is done ex-vivo and arm assignment is based on if the participant is symptomatic or not.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

No study drug will be administered to study participants.

Cohort B

Cohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection.

Group Type EXPERIMENTAL

Blood sample collection

Intervention Type OTHER

No study drug will be administered to study participants.

Interventions

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

No study drug will be administered to study participants.

Intervention Type OTHER

Blood sample collection

No study drug will be administered to study participants.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes