Parkinson's Disease G2019S LRRK2 Genetic Testing Program

NCT ID: NCT04919356

Last Updated: 2023-01-18

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

TERMINATED

Total Enrollment

836 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-08

Study Completion Date

2022-12-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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G2019S LRRK2

No cost genetic testing for G2019S LRRK2

Intervention Type GENETIC

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Engage Health Inc.

INDUSTRY

Sponsor Role collaborator

Sano

OTHER

Sponsor Role collaborator

Escape Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carrolee Barlow, MD, PhD

Role: STUDY_CHAIR

ESCAPE Bio

Locations

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Eurofins Genomic LLC

Louisville, Kentucky, United States

Site Status

Countries

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United States

References

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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/mds.28490. Epub 2021 Feb 11.

Reference Type RESULT
PMID: 33836114 (View on PubMed)

Other Identifiers

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G2019S-001

Identifier Type: -

Identifier Source: org_study_id

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