Questions and Answers about PD GENEration

Program Overview

What is PD GENEration: Mapping the Future of Parkinson’s Disease?

PD GENEration: Mapping the Future of Parkinson’s Disease is a national initiative that offers genetic testing for clinically relevant Parkinson's-related genes and genetic counseling at no cost for people with Parkinson’s disease, in English or Spanish. Additionally, genetic testing results obtained through this study will be confidentially sent to a secure central database for future Parkinson’s-related research.

Who created PD GENEration? Are there any partners involved?

PD GENEration: Mapping the Future of Parkinson’s Disease is a flagship initiative of the Parkinson’s Foundation. Our current corporate study partners include Biogen, Prevail Therapeutics and Sanofi Genzyme. Our genetic testing partner is Fulgent Genetics, a clinical laboratory with extensive experience in next generation genetic testing at scale.

What are the goals of PD GENEration?

PD GENEration provides genetic testing and genetic counseling at no cost to empower people with PD and their care team, improve Parkinson’s care and research and accelerate enrollment in clinical trials.

Specific goals include:

  • Accelerate clinical trials for Parkinson’s: Clinical drug trials that target specific PD-related genes (such as LRRK2, GBA, and SNCA) can find participants and deliver results faster if more people with Parkinson’s know their genetic status.
  • Improve Parkinson’s care and research: PD GENEration provides clinicians and researchers with new tools and knowledge that may lead to novel therapy options for people with Parkinson’s disease. Enrollment in this initiative will allow the largest active clinical trial for PD in the world — the Parkinson’s Outcomes Project — to link genetic status with clinical outcomes.
  • Empower people with Parkinson’s and their care team: Providing people with Parkinson’s disease the ability to attain their genetic data within a clinical setting will allow them to better manage their disease and potentially improve quality of life. Genetic data offer insights into disease progression and symptom severity that may potentially influence clinical care and treatment decisions.

How does PD GENEration differ from other tests?

PD GENEration offers the best, most comprehensive genetic test for people with PD. Offered at no cost for people with PD in English or Spanish, the test is facilitated by a healthcare professional, and results are explained by a genetic counselor through participating Centers of Excellence and Parkinson Study Group sites. Further, PD GENEration pinpoints seven genetic mutations related to PD, whereas other tests are either less specific to PD, or screen for fewer variants related to the disease.

How is PD GENEration funded?

PD GENEration: Mapping the Future of Parkinson’s Disease is a flagship initiative of the Parkinson’s Foundation. Additional financial and in-kind support comes from the Parkinson’s community whom the Foundation represents – industry partners, nonprofit organizations and individuals whose lives have been touched by Parkinson's.

Who can participate in PD GENEration? Are there any age restrictions?

PD GENEration is available to people with a confirmed diagnosis of Parkinson’s disease, regardless of age. For questions about enrollment, email Genetics@Parkinson.org.

If you do not have a confirmed diagnosis of Parkinson’s but are interested in other genetics tests available to test genes related to Parkinson’s, one is Picture PD Aware. Picture PD Aware uses the same test that powers the Parkinson's Foundation PD GENEration study, examining 7 genes associated with the development of Parkinson's disease. The Foundation may receive payment from Picture PD Aware in return for its contribution to the development of the test. Picture PD Aware is for anyone who wants to assess their genetic risk for developing Parkinson’s disease (PD) or a related disorder. This test may be appropriate for those with a family history of PD.

Where is PD GENEration being offered?

Participation can be either in-person at one of our participating Centers of Excellence and Parkinson Study Group sites, or from home through a telemedicine appointment and at-home sample collection kit. For questions about enrollment, email Genetics@Parkinson.org.

If my local Center of Excellence or Parkinson Study Group site is not yet offering PD GENEration, can I still participate at another Center or site?

If you are regularly seen at a Center of Excellence or Parkinson Study Group site that is not yet offering PD GENEration, please contact us at Genetics@Parkinson.org for more information about participating.

Where can I find more information about PD GENEration?

If you’re interested in learning more, please contact us at Genetics@Parkinson.org or visit Parkinson.org/PDGENEration.

You can also call the Parkinson's Foundation Helpline at 1-800-4PD-INFO (1-800-473-4636), to speak with a Parkinson’s specialist in either English or Spanish. The Helpline is open Monday through Friday from 9 a.m. to 7 p.m. ET.

Participation and Logistics

What is genetic testing, and why is it important for Parkinson’s?

Genetic testing, which can be performed through a blood draw or at-home sample collection, is a type of medical test that identifies changes, or variants, in genes. Some of these changes may increase the chances of developing a particular disease or predict which treatment may be more beneficial.

For people with PD, genetic testing can let you know if you carry known gene changes linked to the disease. It’s estimated that 10 percent of people with PD have a genetic form of the disease, so by better understanding how those with genetic forms of PD experience symptoms related to Parkinson’s and respond to treatment, scientists can begin to develop improved treatments and personalized medicines.

A deeper understanding of the genetics of PD may also lead to better treatments themselves by revealing novel therapeutic targets, spurring development of better drugs. Genetic testing can also help people with PD and their clinicians identify whether they may qualify for enrollment in certain clinical trials.

How do I participate in PD GENEration?

People with PD can participate in PD GENEration either in person at participating Centers of Excellence or Parkinson Study Group sites across the U.S., or virtually through an at-home option. Anyone with a PD diagnosis can participate by following these steps:

  • Enroll: Enroll in the study and review the Informed Consent Form at Parkinson.org/PDGENEration.
  • Choose your format: Decide if you would like to participate in-person or at home and schedule your appointment. If participating in-person, select your preferred site. If participating at home, attend a brief virtual screening appointment to confirm your eligibility.
  • Attend your testing appointment: Go to your in-person or virtual PD GENEration genetic testing appointment, where you will complete clinical assessments and sample collection with a healthcare provider. Consider having a loved one, family member or care partner assist you with the appointment.
  • Return your at-home test kit at any FedEx: For virtual participants only, use the pre-paid package and return your at-home test kit at any FedEx location in the U.S.
  • Review your results: Attend a follow-up genetic counseling appointment, either in-person or virtual, where you will receive and review your test results with a genetic counselor.

How much does it cost to participate in PD GENEration?

For people with a confirmed diagnosis of PD, the Parkinson’s Foundation provides genetic testing at no cost – the first national PD study to do so. For people with PD, genetic tests are often not available or not affordable, and not covered by health insurance. By covering the cost for people with PD, the Parkinson’s Foundation hopes to make genetic testing more accessible and empower people with PD and their care team, improve Parkinson’s care and research and accelerate enrollment in clinical trials.

By participating in PD GENEration, people with Parkinson’s disease and their clinicians have the unique opportunity to learn if they carry genetic changes in important Parkinson’s-related genes – knowledge which will help people with PD and their clinicians identify whether they are eligible for enrollment in clinical trials that may ultimately improve treatments and care.

Can I participate in PD GENEration if I’ve already received genetic testing elsewhere?

Yes! People with PD who have already received genetic testing are encouraged to participate in PD GENEration, which may be more comprehensive than other testing experiences. By contributing your genetic testing results to this flagship program, you can help accelerate scientific research to improve understanding of PD and potentially identify new and/or better treatment options.

Can I participate in PD GENEration if I’m not a patient at a Center of Excellence or Parkinson Study Group site?

Potential participants who are not seen at a Center of Excellence or Parkinson Study group site are encouraged to consult with their doctor to discuss genetic testing. Even if you are not an existing patient at a site, you may still participate from home through a site that is accepting telemedicine participants nationwide.

All testing results will be shared back with the participant and their clinician at the Center of Excellence or Parkinson Study Group site. It is highly encouraged that participants allow for testing results to be shared back with the referring physician.

How do I know if I’m a genetic carrier of PD?

A genetic carrier is someone who may carry a change associated with a disease but not display any symptoms. Children or other blood relatives of someone with a PD diagnosis may be genetic carriers of the disease. By receiving genetic testing, you can learn if you carry genetic changes in important Parkinson’s-related genes.

Can potential genetic carriers of Parkinson’s participate in PD GENEration?

Currently, PD GENEration provides genetic testing at no cost to people who have received a Parkinson’s diagnosis. Over time and with additional funding, PD GENEration hopes to expand to offer genetic testing to others, including potential carriers.

People without a PD diagnosis can still participate in genetic testing through a commercial test, though the cost is not covered by the Parkinson’s Foundation. To learn more about this option, visit PictureGenetics.com/PDAware.

How are my genetic data and sample stored? Who can access them?

Your data will be stored and managed centrally at the University of Florida CTSI Data Coordinating Center (UF-CDCC). This electronic system is compliant with data privacy and security according to FDA regulatory requirements per 21 CFR Part 11. Genetic samples collected through the study will be stored by Fulgent Genetics, a CLIA-accredited bio-banking facility. All data shared with the research community will be kept confidential to protect patient health and personal information.

What is a bio-bank?

A bio-bank is a facility that stores biological material (such as human tissue, blood, or DNA) that may be used in scientific research.

How will my participation in PD GENEration support research?

Contributing your genetic data will help scientists in their journey to advance understanding of PD and lead to new, more effective PD therapies. This information will be confidentially sent to a secure central database for future Parkinson’s-related research.

Will my test results impact my health insurance? What about my children’s health insurance? Will my genetic testing results ever be sent to my health insurance company or employer?

Participants’ genetic results will never be shared with third parties such as health insurance companies or employers. Testing results will be securely sent to Centers of Excellence and/or Parkinson Study Group sites that will then confidentially communicate results to participants.

If my test results show a genetic change, does this mean my family members will develop Parkinson's?

Over the years, scientists have studied DNA from people with PD, comparing their genes. They discovered dozens of gene changes linked to PD that are now being researched and studied for what role they play in the disease.

PD is rarely hereditary (passed from generation to generation). If a person tests positive for a certain gene change associated with the disease their risk may increase, but they may never develop PD.

Will the results of my genetic test help determine what treatment I should use?

Currently, genetic test results do not typically affect clinical treatment decision making. PD GENEration is attempting to change that by helping people with PD and their physicians get ready for the next generation of clinical trials that will target specific genetic forms of PD. Our hope is that by increasing the understanding of the connection between Parkinson's and genetics we can help researchers understand how the disease develops and, ultimately, how it can be treated or cured. By participating and contributing your genetic data and sample you have the opportunity to help scientists map the future of PD.

What if, after participating in PD GENEration, I decide I don’t want my data used in research?

Participants can withdraw from the study and remove their bio-banked samples from the study at any time. However, all data collected up until the point of withdrawal from the study will be included in the database in a secure manner.

If companies or researchers profit from scientific discoveries that come out of PD GENEration, will study participants receive compensation?

While we do not anticipate research discoveries to result in revenue, we realize it is a possibility and are looking into ways in which the community could benefit from this type of discovery. Any research agreement will explicitly address this topic and be posted to the Parkinson’s Foundation website once finalized.

Why PD GENEration? Why choose PD GENEration over other available tests?

Not all genetic tests are created equally. PD GENEration offers the best, most comprehensive testing for genetic mutations relevant to Parkinson’s disease, and is facilitated by a healthcare professional and genetic counselor through participating Centers of Excellence and Parkinson Study Group sites. Designed specifically for Parkinson’s, PD GENEration tests for variants of the seven genes most connected to PD – including LRRK2, GBA, and SNCA. Other currently available tests are either less specific to PD, or screen for fewer variants related to the disease.

What data is being collected from PD GENEration participants?

PD GENEration will provide people with PD and their physicians with the detailed knowledge of their genetic status for important Parkinson’s-related genes. In addition, participants will be asked to provide their family history of PD, current medication dosage and other relevant medical data.

Outcomes

How have you advanced research so far? How close are you to discovering a cure?

An estimated one million people in the U.S. are living with PD. Through PD GENEration, we aim to identify the subset of people with PD who have genetic mutations in GBA, a mutation specific to Parkinson’s seen in 10 percent of people with PD. Once identified, we help them find enrollment in clinical studies in order to make breakthroughs leading to better treatment and a cure for this disease.

PD GENEration data are analyzed in real-time by global researchers through the Parkinson’s Foundation’s leadership in forming the expert panel for NIH ClinGen. So far, more than 15 percent of participants have been found to have a genetic form of PD.

How will my donation to PD GENEration be used?

Your donation will be used to support the operational costs associated with implementing this national study, including but not limited to, purchasing genetic testing kits, supporting genetic counseling, developing guidance and resources for study participants.

Who has access to the database of collected data and samples?

The Parkinson’s Foundation is the sole owner of the data and samples, whose purpose is to help benefit research. With a vision to best serve the interests of the PD community, data and samples collected through this program will never be sold to a third-party. Only approved researchers will gain access to the database, to be used for research purposes only.

What types of questions will researchers be able to answer using data from PD GENEration?

Data from PD GENEration may help researchers answer questions such as:

  • How do genetics and the environment contribute to a person’s experience with PD?
  • Which genetic changes contribute to developing PD?
  • Why do some people develop PD while others do not?
  • How and why does each person’s experience with PD differ?

How have patients and their families benefitted from participating so far?

By enrolling in PD GENEration, each participant is learning about his or her genetic profile and if they have variants on some of the genes that have been linked to PD. All of this data informs future research on treatment options that may provide much-needed breakthroughs for PD patients and their families.

Can researchers access the genetic samples and data collected through PD GENEration?

Yes. Anonymized, confidential data from PD GENEration is open to researchers working to develop new tools, knowledge and therapy options for people with PD. Enrollment in this flagship initiative will also allow the largest, active clinical trial for PD in the world — the Parkinson’s Outcomes Project — to link genetic status with clinical outcomes. Participants’ DNA and blood samples will continue to be securely stored to allow potential testing for new Parkinson’s genes discovered in the future.

Who will be eligible to access data collected through PD GENEration?

Only researchers approved by the Parkinson’s Foundation will be eligible to access the database. All approved researchers will be required to sign a data use agreement to comply with the Parkinson’s Foundation’s terms for use, indicating that the data and samples are to be used for research purposes only.

When will researchers be able to access the data collected through PD GENEration?

We hope to make the genetic data accessible to the research community on an ongoing, regular/scheduled basis to accelerate novel scientific findings and spur new research for PD.

Parkinson's Disease Background

What is Parkinson’s disease?

PD is a neurodegenerative, progressive disorder that affects dopamine-producing neurons in a specific area of the brain called substantia nigra. People with PD may experience a tremor, slowness of movements, gait and balance problems, and non-motor symptoms including depression, anxiety, constipation and cognitive impairment.

Who is affected by Parkinson’s disease?

Incidence of PD increases with age. An estimated four percent of people with PD are diagnosed before age 50, and men are 1.5 times more likely to have PD than women.

How many people are affected by Parkinson’s disease?

Nearly one million Americans and 10 million people worldwide live with PD, making it the second most common neurodegenerative condition after Alzheimer’s.

Approximately 60,000 Americans are diagnosed with PD each year. The number of people with PD will increase substantially in the next 20 years due to the aging of the population.

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