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Abstract: Background: The Movement Disorder Society‐Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) is a commonly used tool to measure progression in patients with Parkinson's disease (PD). Longitudinal changes in MDS‐UPDRS scores in patients with de novo PD have not been established. The objective of this study was to determine progression rates of MDS‐UPDRS scores in de novo PD. Methods: In total, 362 participants from the Parkinson's Progression Markers Initiative, a multicenter, longitudinal cohort study of de novo PD, were included. Longitudinal progression of MDS‐UPDRS total and subscale scores were modeled using mixed model regression. Results: MDS‐UPDRS scores increased in a linear fashion over 5 years in patients with de novo PD. MDS‐UPDRS total scores increased an estimated 4.7 points per year, Part I scores increased 0.92 points per year, Part II scores increased 0.99 points per year, and Part III scores increased 2.4 points per year. Conclusions: The expected average progression of MDS‐UPDRS scores in patients with de novo PD from this study can assist in clinical monitoring and provide comparative data for the detection of disease modification in treatment trials. [ABSTRACT FROM AUTHOR]

Background Parkinson's disease ( PD) dementia ( PDD) is a major cause of morbidity and mortality in PD, which severely affects patient functioning and quality of life and increases the risk for nursing home admission. Unfortunately, current treatment options for PDD are limited and have only marginal therapeutic effects. As novel treatments are developed, there will be a need to assess their efficacy in well-designed, randomized, controlled trials. However, there is no consensus on the optimal outcome measures for use in PDD clinical trials. Methods A systematic review of PDD clinical trials and empirical studies of outcome measures used in PDD was performed. Outcome measures were divided into 5 categories: (1) cognitive; (2) behavioral and mood; (3) activities of daily living and quality of life; (4) global; and (5) caregiver burden. Findings A total of 20 PDD pharmacological clinical trials were identified. These trials incorporated a broad array of outcome measures, which were used inconsistently across trials. We summarize the psychometric properties and other relevant data on outcome measures used, including their diagnostic utility, inter-rater reliability, test-retest reliability, responsiveness, clinically meaningful change, and availability of alternate forms. Conclusions We have identified the best-evidenced PDD outcome measures in each domain. Further research is needed to assess the validity, reliability, and clinically meaningful change of these measures in PDD to inform the design of future clinical trials and enhance the ability of clinicians, researchers, and policy makers to interpret study results. In addition, the development of outcome measures specific to PDD may be warranted. [ABSTRACT FROM AUTHOR]