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Trial record 1 of 1 for:    NCT04919356
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Parkinson's Disease G2019S LRRK2 Genetic Testing Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04919356
Recruitment Status : Active, not recruiting
First Posted : June 9, 2021
Last Update Posted : August 16, 2022
Sponsor:
Collaborators:
Engage Health Inc.
Sano
Information provided by (Responsible Party):
Escape Bio, Inc.

Tracking Information
First Submitted Date June 4, 2021
First Posted Date June 9, 2021
Last Update Posted Date August 16, 2022
Actual Study Start Date June 8, 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2021)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 4, 2021)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Parkinson's Disease G2019S LRRK2 Genetic Testing Program
Official Title G2019S LRRK2 Parkinson's Disease: Increasing Awareness and Genetic Testing Program
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Data generation using next-generation sequencing (NGS) of human exons
Sampling Method Probability Sample
Study Population A clinical diagnosis of Parkinson's disease
Condition Parkinson's Disease
Intervention Genetic: G2019S LRRK2
No cost genetic testing for G2019S LRRK2
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 4, 2021)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04919356
Other Study ID Numbers G2019S-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Escape Bio, Inc.
Original Responsible Party Same as current
Current Study Sponsor Escape Bio, Inc.
Original Study Sponsor Same as current
Collaborators
  • Engage Health Inc.
  • Sano
Investigators
Study Chair: Carrolee Barlow, MD, PhD ESCAPE Bio
PRS Account Escape Bio, Inc.
Verification Date August 2022