PDGeneration: Mapping the Future of Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease

Conditions
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Parkinson's Disease and Parkinsonism

Intervention / Treatment
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* Device: Lab Assay for seven genetic variants for Parkinson's Disease
* Device: Lab Assay for seven genetic variants for Parkinson's Disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Site-Based Genetic Counseling<br>Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site. | Device: Lab Assay for seven genetic variants for Parkinson's Disease<br>* Counseling provided to participant by site clinician/physician/genetic counselor.<br>|
| Active Comparator: Centralized Genetic Counseling<br>Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University. | Device: Lab Assay for seven genetic variants for Parkinson's Disease<br>* Counseling provided to participant by centralized genetic counseling group at Indiana University.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of genetic testing and counseling | The total number of participants who receive genetic testing and counseling. | 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. | 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. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that enroll in precision medicine trials | Number of participants that enroll in precision medicine trials | 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. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's, Genetics, PD Genetics