Objective: To explore the utility of assessing emergence of new symptoms (ES) impacting the daily experiences of patients with early Parkinson’s disease (PD) in relation to the initiation of antiparkinsonian therapy (STx) as an outcome measure during the early phase of the disease.

Background: Studies in patients with early Alzheimer’s disease have tracked the appearance of new neuropsychiatric symptoms, suggesting clinical relevance of ES when associated with increased morbidity ⁽¹⁾. Determining how ES in PD reflect the course and treatment of the disease could inform development of new clinical outcome assessments.

Method: The study population included 331 participants in the Safety, Tolerability, and Efficacy Assessment of Isradipine for PD (STEADY-PD) study, who had complete data from MDS-UPDRS Part IB (Non-motor Aspects of Experiences of Daily Living) and Part II (Motor Aspects of Experiences of Daily Living), and at least one annual follow-up over two years. We analyzed the number of ES for each part of the scale and assessed differences between subjects who started symptomatic treatment (STx-yes) and those who did not (STx-no) between 0 and 12 months or between 13 and 24 months of follow-up using Mann-Whitney U test.

Results: Of 331 subjects observed for months 0 to 12, 288 (87%) developed ES, and 182 (55%) started STx. For Part 1B, the median number of ES did not significantly differ between the STx-yes group and the STx-no group (Z=-0.86, p = 0.39). For Part 2, the number of ES was significantly higher for the STx-yes group compared to the STx-no group (Z=-2.38, p=0.02). Of 148 subjects observed for months 13 to 24, 114 (77%) developed ES, and 62 (42%) started STx. For Part 1B, the median number of ES did not significantly differ between the STx-yes group and the STx-no group (Z=-0.33, p = 0.74). For Part 2, the number of ES was significantly higher for the STx-yes group compared to the STx-no group (Z=-2.25, p=0.02).

Conclusion: New symptoms continue to appear in most patients in the first 2 years of PD. Motor ES (Part II) were more frequent than non-motor ES (Part IB) among subjects initiating antiparkinsonian treatment in both 0-12 and 13-24 months of the study. Assessing ES among patient-reported experiences of daily living may provide a useful marker for tracking PD progression.

References: 1. Tariot P, Lyketsos C, Crans G, Cedarbaum J, Hernandez C, Abushakra S (Susan). The Effects of ELND005 (Scyllo-Inositol) on Emergence of Neuropsychiatric Symptoms (NPS) in Mild/Moderate Alzheimers Disease: Results from a 78-Week Phase 2 Study (P04.215). Neurology. 2012;78(1 Supplement):P04.215 LP-P04.215.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/emergence-of-new-symptoms-in-experiences-of-daily-living-in-early-parkinsons-disease/