Parkinson's Disease and ParkinsonismPDGENENCT04057794
PDGeneration: Mapping the Future of Parkinson's Disease
A study testing Lab Assay for seven genetic variants for Parkinson's Disease in people with Parkinson's Disease and Parkinsonism, run by Parkinson's Foundation at 13 sites in United States.
Trial summary
To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease and Parkinsonism
- What is being tested?
- Lab Assay for seven genetic variants for Parkinson's Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,982 participants
- Where
- 13 sitesUnited States
- Study dates
- 15 Aug 2019to 15 Apr 2025
- Phase
- Interventional
- 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
Who may be able to join
- Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
- Willingness to undergo genetic testing, and choose to be informed of genetic testing results for Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
- Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
- Able to perform study activities (including completion of either online, in-person or paper surveys).
- Individuals must speak and understand the language of the informed consent.
Who cannot join
- Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
- Individuals who have received a blood transfusion within the past 3 months.
- Individuals who have active hematologic malignancies such as lymphoma or leukemia.
- Individuals who have had a bone marrow transplant within the past 5 years.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Massachusetts General Hospital
Boston, Massachusetts, 02129
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
University of Miami
Fort Lauderdale, Florida, 33308
Baylor College of Medicine
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California San Diego (UCSD)
La Jolla, California, 92093
Health Partners/Park Nicollet: Struthers Parkinson's Center
Minneapolis, Minnesota, 55427
Beth Israel Medical Center
New York, New York, 10003
Columbia University
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Cleveland Clinic Florida-Weston
Weston, Florida, 33331
About this study
Official title: Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease
To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).
Read the detailed description
The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through Indiana University. The study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. All genetic test results will be returned to participants through a genetic counseling visit.
- Conditions
- Parkinson's Disease and Parkinsonism
- Being tested
- Lab Assay for seven genetic variants for Parkinson's Disease
- Keywords
- Parkinson's, Genetics, PD Genetics
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab Assay for seven genetic variants for Parkinson's DiseaseDevice
Counseling provided to participant by site clinician/physician/genetic counselor.
Lab Assay for seven genetic variants for Parkinson's DiseaseDevice
Counseling provided to participant by centralized genetic counseling group at Indiana University.
| Study group | Role | What they receive |
|---|---|---|
| Site-Based Genetic Counseling | Active comparator | Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site. Receives: Device: Lab Assay for seven genetic variants for Parkinson's Disease |
| Centralized Genetic Counseling | Active comparator | Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University. Receives: Device: Lab Assay for seven genetic variants for Parkinson's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of genetic testing and counseling
The total number of participants who receive genetic testing and counseling.
Measured: up to 24 weeks
Impact Evaluation
The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling.
Measured: up to 6 months
Satisfaction Comparison
Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score.
Measured: up to 6 months
Secondary outcomes (2)
Number of participants that enroll in precision medicine trials
Number of participants that enroll in precision medicine trials
Measured: up to 12 months
Time it takes between first contact to the return of genetic test results
Number of weeks it takes between participant consent to return of genetic test results.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start15 Aug 2019
- Primary completion1 Dec 2021
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease and ParkinsonismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
- Masking
- None (open label)
- Enrolment
- 1,982 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkinson's Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Fulgent Laboratories, Indiana University, The Parkinson Study Group, Navitas Clinical Research, Inc
- Responsible party
- Sponsor
- Investigators
- Roy N Alcalay, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057794
- Sponsor's protocol ID
- PDGene-01
- Acronym
- PDGENE
- Status last verified
- Jul 2023
- First submitted
- 6 Aug 2019
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04057794
- Acronym / sponsor ID
- PDGENE / PDGene-01
- Conditions
- Parkinson's Disease and Parkinsonism
- Keywords
- Parkinson's, Genetics, PD Genetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,982 participants (actual)
- Lead sponsor
- Parkinson's FoundationUniversity, hospital or other
- Collaborators
- Fulgent Laboratories, Indiana University, The Parkinson Study Group, Navitas Clinical Research, Inc
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 15 Aug 2019 (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.
To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).
Detailed description
The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through Indiana University. The study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. All genetic test results will be returned to participants through a genetic counseling visit.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
| Arm | Type | Receives |
|---|---|---|
| Site-Based Genetic Counseling | Active comparator | Device: Lab Assay for seven genetic variants for Parkinson's DiseaseParticipants randomized to this arm will receive genetic counseling for genetic results through the enrolling site. |
| Centralized Genetic Counseling | Active comparator | Device: Lab Assay for seven genetic variants for Parkinson's DiseaseParticipants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
- Willingness to undergo genetic testing, and choose to be informed of genetic testing results for Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
- Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
- Able to perform study activities (including completion of either online, in-person or paper surveys).
- Individuals must speak and understand the language of the informed consent.
Key exclusion criteria (4 listed)
- Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
- Individuals who have received a blood transfusion within the past 3 months.
- Individuals who have active hematologic malignancies such as lymphoma or leukemia.
- Individuals who have had a bone marrow transplant within the past 5 years.
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 |
|---|---|---|
| Lab Assay for seven genetic variants for Parkinson's DiseaseCounseling provided to participant by site clinician/physician/genetic counselor. | Device | Site-Based Genetic Counseling |
| Lab Assay for seven genetic variants for Parkinson's DiseaseCounseling provided to participant by centralized genetic counseling group at Indiana University. | Device | Centralized Genetic Counseling |
Primary outcome
Feasibility of genetic testing and counseling
Time frame: up to 24 weeks
The total number of participants who receive genetic testing and counseling.
Impact Evaluation
Time frame: up to 6 months
The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling.
Satisfaction Comparison
Time frame: up to 6 months
Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score.
2 secondary outcomes
Number of participants that enroll in precision medicine trials
Time frame: up to 12 months
Time it takes between first contact to the return of genetic test results
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- For more information and to enroll, please visit the website.Link provided by the sponsor.
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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.
Roy N Alcalay, MD, MS principal investigator
Columbia University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab Assay for seven genetic variants for Parkinson's Disease in people with Parkinson's Disease and Parkinsonism, run by Parkinson's Foundation at 13 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
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?
Feasibility of genetic testing and counseling (time frame: up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.