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TerminatedNCT04919356Updated Jan 18, 2023

Parkinson's Disease G2019S LRRK2 Genetic Testing Program

An observational study in Parkinson's Disease, sponsored by Escape Bio, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Escape Bio, Inc. · Observational

Why this study was terminated
Sponsor stopped the study
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
836
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Parkinson's Disease

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Keywords

  • G2019S LRRK2 Mutation
  • Young Onset
  • Genetic
  • Ashkenazi Jewish Descent
  • North African Berber
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In context

Parkinson Disease

4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.

This study's enrollment of 836 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Escape Bio, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

A clinical diagnosis of Parkinson's disease

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

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
836 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • GeneticG2019S LRRK2

    No cost genetic testing for G2019S LRRK2

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

  3. Increase interest of healthcare providers and patients participation in clinical trials

    To engage healthcare providers and patients' interest in participation in upcoming clinical studies.

    Time frame: 2 years

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Study locations

1 site
  • Eurofins Genomic LLC
    Louisville, Kentucky 40299, United States
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References and documents

Publications

  • 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. PubMed 33836114 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04919356
Lead sponsor
Escape Bio, Inc.
Collaborators
Engage Health Inc., Sano
Responsible party
Sponsor
First posted
Jun 9, 2021
Start date
Jun 8, 2021
Primary completion
Dec 5, 2022
Completion
Dec 5, 2022
Last update
Jan 18, 2023

Study contacts

Carrolee Barlow, MD, PhD
study chair · ESCAPE Bio
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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