Parkinson's Disease G2019S LRRK2 Genetic Testing Program

January 16, 2023 updated by: Escape Bio, Inc.

G2019S LRRK2 Parkinson's Disease: Increasing Awareness and Genetic Testing Program

Increase awareness of the G2019S LRRK2 mutation in Parkinson's and no cost genetic testing program.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This program is intended to increase awareness of genetic Parkinson's, in particular the G2019S LRRK2 mutation, and provide no cost genetic testing to determine if they carry the G2019S LRRK2 mutation.

Study Type

Observational

Enrollment (Actual)

836

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40299
        • Eurofins Genomic LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A clinical diagnosis of Parkinson's disease

Description

Participants include those with a clinical diagnosis of Parkinson's, in particular those who have a first- or second-degree relative with Parkinson's, or who have young onset Parkinson's (age less than 50 at diagnosis) or are of Ashkenazi Jewish or North African Berber descent, or have a relative with a known genetic mutation in the LRRK2 gene, or who have a genetic mutation in the LRRK2 gene.

Inclusion Criteria:

Participant eligible for enrollment in the program must meet all of the following criteria:

  1. Participant must be a person diagnosed with Parkinson's disease who is 18 years or older.
  2. Participant is under the care of a physician for their Parkinson's disease.
  3. Participant is able to read, write and understand English, and reside in a country where the shipment of biological samples is allowed.
  4. Participant is able to grant informed consent.
  5. In the case of participants, willing to participate in a free genetic testing program to determine if they carry the G2019S LRRK2 mutation.
  6. Willing to be notified of eligibility for clinical studies (if appropriate).
  7. Particpants who already believe they have tested positive for the mutation will be allowed to be retested through this program and be notified of potential eligibility for studies.

Exclusion Criteria:

  1. Inability to meet any of the inclusion criteria.
  2. Participant has received on of the following advanced treatments to manage their Parkinson's: gene therapy, deep brain stimulation (DBS), injections into the brain, continuous infusion of medication into their stomach/intestines with a pump.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify Parkinson's patients with the G2019S mutation in their LRRK2 gene
Time Frame: 2 years
To identify Parkinson's patients with the G2019S mutation in their LRRK2 gene through whole exome sequencing in order to support the development of an oral precision medicine.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understand the proportion of Parkinson's patients who have a G2019S LRRK2 mutation
Time Frame: 2 years
To obtain information about the proportion of Parkinson's patients who have a G2019S LRRK2 mutation.
2 years
Increase awareness of the importance of genetic testing in Parkinson's disease
Time Frame: 2 years
To increase healthcare provider and patient awareness of the importance of genetic testing in Parkinson's disease in order to be aware of potential eligibility for clinical studies of genetic targeted medicines.
2 years
Increase interest of healthcare providers and patients participation in clinical trials
Time Frame: 2 years
To engage healthcare providers and patients' interest in participation in upcoming clinical studies.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escape Bio, Inc.

Collaborators

Engage Health Inc.
Sano

Investigators

  • Study Chair: Carrolee Barlow, MD, PhD, ESCAPE Bio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G2019S-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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