Parkinson's Disease G2019S LRRK2 Genetic Testing Program

Terminated

• Conditions: Parkinson's Disease

• Registration Number: NCT04919356
• Lead Sponsor: Escape Bio, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Study Start: 2021-06-08
• Study First Posted: 2021-06-09
• Status Verified: 2022-08
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-05
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 836

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify Parkinson's patients with the G2019S mutation in their LRRK2 gene	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.

Secondary Outcome Measures

Name	Time	Method
Understand the proportion of Parkinson's patients who have a G2019S LRRK2 mutation	2 years	To obtain information about the proportion of Parkinson's patients who have a G2019S LRRK2 mutation.
Increase awareness of the importance of genetic testing in Parkinson's disease	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.
Increase interest of healthcare providers and patients participation in clinical trials	2 years	To engage healthcare providers and patients' interest in participation in upcoming clinical studies.

Trial Locations

Locations (1)

Eurofins Genomic LLC; 🇺🇸 Louisville, Kentucky, United States