Parkinson's DiseaseNCT04919356
Parkinson's Disease G2019S LRRK2 Genetic Testing Program
An observational study of Parkinson's Disease, run by Escape Bio, Inc. at 1 site in United States.
Trial summary
Increase awareness of the G2019S LRRK2 mutation in Parkinson's and no cost genetic testing program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- G2019S LRRK2
- How many people
- 836 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 5 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A clinical diagnosis of Parkinson's disease
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: G2019S LRRK2 Parkinson's Disease: Increasing Awareness and Genetic Testing Program
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.
- Conditions
- Parkinson's Disease
- Being tested
- G2019S LRRK2
- Keywords
- G2019S LRRK2 Mutation, Young Onset, Genetic, Ashkenazi Jewish Descent, North African Berber
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G2019S LRRK2Genetic
No cost genetic testing for G2019S LRRK2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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.
Measured: 2 years
Increase interest of healthcare providers and patients participation in clinical trials
To engage healthcare providers and patients' interest in participation in upcoming clinical studies.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start8 Jun 2021
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Why it stopped: Sponsor stopped the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escape Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Engage Health Inc., Sano
- Responsible party
- Sponsor
- Investigators
- Carrolee Barlow, MD, PhD, Study chair, ESCAPE Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919356
- Sponsor's protocol ID
- G2019S-001
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G2019S LRRK2 Parkinson's Disease: Increasing Awareness and Genetic Testing Program
- ClinicalTrials.gov ID
- NCT04919356
- Acronym / sponsor ID
- G2019S-001
- Conditions
- Parkinson's Disease
- Keywords
- G2019S LRRK2 Mutation, Young Onset, Genetic, Ashkenazi Jewish Descent, North African Berber
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor stopped the study
- Enrolment
- 836 participants (actual)
- Lead sponsor
- Escape Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Engage Health Inc., Sano
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A clinical diagnosis of Parkinson's disease
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G2019S LRRK2No cost genetic testing for G2019S LRRK2 | Genetic | – |
Primary outcome
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.
3 secondary outcomes
Understand the proportion of Parkinson's patients who have a G2019S LRRK2 mutation
Time frame: 2 years
Increase awareness of the importance of genetic testing in Parkinson's disease
Time frame: 2 years
Increase interest of healthcare providers and patients participation in clinical trials
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor stopped the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Results publication: PubMed 33836114Bright 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrolee Barlow, MD, PhD study chair
ESCAPE Bio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Escape Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor stopped the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Parkinson's patients with the G2019S mutation in their LRRK2 gene (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.