Parkinson's Disease G2019S LRRK2 Genetic Testing Program
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|ClinicalTrials.gov Identifier: NCT04919356|
Recruitment Status : Terminated (Sponsor stopped the study)
First Posted : June 9, 2021
Last Update Posted : January 18, 2023
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|Condition or disease||Intervention/treatment|
|Parkinson's Disease||Genetic: G2019S LRRK2|
|Study Type :||Observational|
|Actual Enrollment :||836 participants|
|Official Title:||G2019S LRRK2 Parkinson's Disease: Increasing Awareness and Genetic Testing Program|
|Actual Study Start Date :||June 8, 2021|
|Actual Primary Completion Date :||December 5, 2022|
|Actual Study Completion Date :||December 5, 2022|
- Genetic: G2019S LRRK2
No cost genetic testing for G2019S LRRK2
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
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.
Participant eligible for enrollment in the program must meet all of the following criteria:
- Participant must be a person diagnosed with Parkinson's disease who is 18 years or older.
- Participant is under the care of a physician for their Parkinson's disease.
- Participant is able to read, write and understand English, and reside in a country where the shipment of biological samples is allowed.
- Participant is able to grant informed consent.
- In the case of participants, willing to participate in a free genetic testing program to determine if they carry the G2019S LRRK2 mutation.
- Willing to be notified of eligibility for clinical studies (if appropriate).
- 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.
- Inability to meet any of the inclusion criteria.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919356
|United States, Kentucky|
|Eurofins Genomic LLC|
|Louisville, Kentucky, United States, 40299|
|Study Chair:||Carrolee Barlow, MD, PhD||ESCAPE Bio|
|Responsible Party:||Escape Bio, Inc.|
|Other Study ID Numbers:||
|First Posted:||June 9, 2021 Key Record Dates|
|Last Update Posted:||January 18, 2023|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
G2019S LRRK2 Mutation
Ashkenazi Jewish Descent
North African Berber
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases