Study Rationale: In individuals with Parkinson’s disease (PD), the pathological processes are already advanced by the time a clinical diagnosis is made. This delay contributes to the difficulty in slowing disease progression once symptoms are manifest. A promising alternative would be to delay or even prevent the onset of clinically manifest PD by intervening during the lengthy, prodromal phase of the disease. Individuals with PD spend considerably time in the prodromal phase before converting to clinically manifest PD. Therefore, future prevention trials should incorporate intermediate measures of disease progression that can be assessed serially while participants are still in the prodromal phase.
Hypothesis: We hypothesize that the severity of prodromal PD pathology can be accurately estimated by integrating digital biomarkers of emerging, motor and non-motor prodromal PD features into a composite Prodromal Load Score.
Study Design: We will use participant data from existing prospective cohort studies to develop a composite Prodromal Load Score based on digital measures of motor and non-motor prodromal features of PD. We will then externally validate the Prodromal Load Score across complementary cohorts. The score will then be used to assess the possible efficacy of an exercise intervention to slow the progression of the earliest phase of PD in a first-of-its kind prototype prevention trial of PD, entitled “Slow-SPEED.”
Impact on Diagnosis/Treatment of Parkinson’s Disease: If validated, the Prodromal Load Score could be used as an intermediate outcome measure in an array of future prevention trials of PD, including the many pharmacological trials that are currently being prepared. If successful, this project could therefore significantly shape the design of PD prevention efforts in the future.
Next Steps for Development: We anticipate that digital biomarkers will be incorporated in additional prospective cohort studies of traditionally underserved populations in the coming years. When that occurs, we will work with these cohorts to facilitate stratum-specific finetuning of the Prodromal Load Score.
Trial Phase II