Parkinson's Disease G2019S LRRK2 Genetic Testing Program

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04919356
• Other study ID #: G2019S-001
• Status: Terminated
• Start date: June 8, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: August 2022
• Source: Escape Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 836
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Genetic:
• G2019S LRRK2
No cost genetic testing for G2019S LRRK2

Locations

Country	Name	City	State
United States	Eurofins Genomic LLC	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Escape Bio, Inc.	Engage Health Inc., Sano

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bright JM, Carlisle HJ, Toda AMA, Murphy M, Molitor TP, Wren P, Andruska KM, Liu E, Barlow C. Differential Inhibition of LRRK2 in Parkinson's Disease Patient Blood by a G2019S Selective LRRK2 Inhibitor. Mov Disord. 2021 Jun;36(6):1362-1371. doi: 10.1002/m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify Parkinson's patients with the G2019S mutation in their LRRK2 gene	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	Understand the proportion of Parkinson's patients who have a G2019S LRRK2 mutation	To obtain information about the proportion of Parkinson's patients who have a G2019S LRRK2 mutation.	2 years
Secondary	Increase awareness of the importance of genetic testing in Parkinson's disease	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
Secondary	Increase interest of healthcare providers and patients participation in clinical trials	To engage healthcare providers and patients' interest in participation in upcoming clinical studies.	2 years