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Using the Emergence of New Symptoms as a Measure for Parkinson’s Disease Progression in Clinical Trials

Study Rationale: Studies suggest that as Parkinson’s disease (PD) progresses, new areas of the brain fall prey to PD pathology. If this is the case, PD progression may be best assessed by tracking the emergence of new symptoms, as opposed to evaluating the severity of all symptoms, both new and old. We recently found that counting the appearance of new symptoms — as reported in Parts Ib and II of the MDS-sponsored revision of the Unified Parkinson’s Disease Ratings Scale (MDS-UPDRS) — is an effective means of monitoring disease progression in early PD. In this study, we will repeat and confirm our earlier findings using additional data sets.

Hypothesis: We hypothesize that using the MDS-UPDRS to count the appearance of new symptoms will provide a more sensitive means of monitoring early PD progression than the standard methods, which include assessment of both new and old symptoms. 

Study Design: Using data from a recently completed clinical trial, which includes more frequent administration of the MDS-UPDRS, we will confirm our previous findings and examine whether the threshold values selected to identify new symptoms (for example, a score of 1 or 2) affect the sensitivity of the new measure. We will also evaluate whether patients continue to report new symptoms after starting symptomatic medications and assess the relationship between starting symptomatic treatment and symptom emergence over time. Finally, we will compare how our new method of analysis compares with standard approach to using MDS-UPDRS scores.

Impact on Diagnosis/Treatment of Parkinson’s disease: If successful, our study will validate an approach to scoring Parts I and II of the MDS-UPDRS that would enable smaller, shorter clinical trials using the MDS-UPDRS as a patient-reported outcome measure.

Next Steps for Development: Once verified, our new method could be applied in ongoing and future PD clinical trials, and it could serve as the basis for developing similar tools for use in studies of prodromal PD as well as other neurological disorders.


  • Jesse M. Cedarbaum, MD

    Woodbrdige, CT United States

  • Sheng Luo, PhD

    Durham, NC United States

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