ROPAD Study of Parkinson’s Genetics Enrolling 2,500 More Patients

Centogene announced plans to recruit 2,500 more patients this year into its observational Rostock International Parkinson’s Disease (ROPAD) study of how genetic factors contribute to the development of Parkinson’s.

“We recently reached a significant study milestone, but this is just the beginning,” Peter Bauer, MD, Centogene’s chief genomic officer, said in a press release.

“By extending this study … we will be able to unveil deeper data on Parkinson’s disease genetics, diagnose patients earlier, and accelerate personalized Parkinson’s treatments,” he added.

The study (NCT03866603) met its two-year milestone in March, with genetic tests given to 10,000 enrolled patients across 120 sites worldwide. Centogene performs genetic analysis using its proprietary dried blood spot collection kit called CentoCard, and its gene sequencing technologies.

Based on initial findings, the trial’s expansion will focus on 40 study sites across 11 countries, including in Brazil, Germany, Italy, Spain, and the U.S. Plans are to enroll and test this new patient group by year’s end.

ROPAD primarily aims to understand the role of genetic variability in Parkinson’s. Centogene anticipates that this will lead to a better understanding of how the disorder develops, how to predict its severity, and how to more quickly and accurately diagnose it.

The study is also assessing the number of patients carrying mutations in the LRRK2 gene, which are one of most common genetic causes of familial Parkinson’s. Researchers are also looking at the prevalence of mutations in other genes linked to this disease, such as GBA.

People with LRRK2 gene mutations may also be eligible to move into other clinical studies, both ongoing and planned.

These include the LRRK2 International Parkinson’s Disease Project (LIPAD, NCT04214509), underway at the University of Lübeck. This study, which is currently recruiting, aims to systematically characterize Parkinson’s patients with mutations in the LRRK2 gene.

Also, a late-stage trial is planned for DNL151, a potential oral LRRK2 inhibitor being developed by Denali Therapeutics — a partner in the ROPAD study — in collaboration with Biogen.

ROPAD’s protocol and preliminary results are in the study “The Rostock International Parkinson’s Disease (ROPAD) Study: Protocol and Initial Findings,” published in the journal Movement Disorders.

Early results, covering the first 1,360 patients screened, indicated that ROPAD’s screening protocol works in a large-scale setting. Screening led to a roughly 14% positive diagnostic yield, meaning mutations in Parkinson’s-associated genes like LRRK2 were found in about 14% of this patient group.

Centogene’s Bauer did not detail reasons for extending ROPAD and screening another 2,500 patients, beyond given goals of advancing diagnosis, disease understanding, and the likelihood of personalized treatments.

“There are several steps ahead that need to be taken to get patients the solutions they need,” he simply said.