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Despite researchers' best efforts, Parkinson's disease remains incurable. While there are treatment options that mitigate some symptoms, assigning the right treatment approach can be hit or miss. To better predict the response of Parkinson's patients to therapy, the Cleveland Clinic has joined consumer genomics company 23andMe in its Parkinson's Community Research Project. Enrollment in the program will also allow the clinic's patients to take advantage of 23andMe's Personal Genome Service.

23andMe began its Parkinson's disease collaboration in 2009 when it teamed up with the Michael J. Fox Foundation for Parkinson's Research and the Parkinson's Institute and Clinical Center. After roughly 18 months, the collaboration had assembled and analyzed genetic data from more than 3,400 Parkinson's patients, found 20 previously known genetic associations, and identified two novel loci — rs6812193 near SCARB2 and rs11868035 near SREBF1/RA11. Ultimately, the collaboration aims to enroll 10,000 people. To date, 23andMe has enrolled roughly 6,500 patients, and the Cleveland Clinic is planning to add another 1,000 patients.

For clinicians like Andre Machado, director of the Cleveland Clinic's Center for Neurological Restoration, the ideal scenario is that this large-scale collaboration can produce a roadmap to advance treatments for Parkinson's patients. "We're hoping to get data on the progression or responsiveness to a given type of treatment, things that can help us understand maybe in the future how to select treatments that are more likely to work for some patients versus others," Machado says.

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The process starts by reaching out to patients diagnosed with Parkinson's disease by their neurologists and inviting them to participate. "Because this study aims to find novel genetic variants associated with Parkinson's disease by way of genome-wide association studies, it is crucial that the group of whose genes are being analyzed have a pure diagnosis of Parkinson's disease, as opposed to parkinsonism," says Kathryn Teng, director of the Center for Personalized Healthcare at the Cleveland Clinic. "As with all genome-wide association studies, in order to get pure results, you need to have pure data going into the study."

One enrollment challenge, Teng says, is that participants might be older, and therefore less comfortable with computers. "The 23andMe model requires electronic enrollment and participation in surveys, so family members may need to assist with the enrollment and data collection if the patient requires assistance," she adds.

Reaching the desired sample size is also made difficult by a lack of familiarity with genetic research in some pockets of the target population. "Many may not be aware of the protections offered by the GINA law which protects against discrimination based on genetic information for health insurance and employment," Teng says. To assuage any anxieties, potential recruits are told that they and their DNA samples will only be identified by a unique code. They are also told that the reports that they receive through 23andMe's website summarizing the genes identified in their DNA will not be part of their medical record.

To make participation as easy as possible, the Cleveland Clinic has dedicated computer portals set up at locations where Parkinson's patients are likely to visit, including its various campuses.

Ultimately, Machado says he does not know if 10,000 patients will be a large enough sample size to effectively interrogate the data to make a difference on treatment. However, he adds, the collaboration with 23andMe provides "an opportunity for doing exploration and there is a chance that it will benefit patients down the line."

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