TD‐P‐014: Dementia Talk App

Abstract

clinical guidance to standardize outcome measurements and improve data quality. In the present study, we compared paperbased administrations against administration with Virgil to determine the extent to which the use of electronic assessments (eCOA) minimized scoring errors in primary and co-primary endpoints of AD trials. Methods:Paper-based assessments from a recent clinical trial of mild cognitive impairment (MCI) were compared against eCOA administrations of the same scales in separate MCI trials. All studies are phase II/III multinational trials. Score discrepancies in CDR, ADAS-Cog, ADCS-ADL-MCI, and MMSE were identified via review of audio recordings and worksheets by the same cohort of expert calibrated reviewers. For each scale, discrepancies were compared between paper-based and Virgil administrations. Results: Percentages of reviews with at least one scoring discrepancy, as well as two or more discrepancies, were significantly and substantially lower in Virgil administrations compared to paper-based for all scales. Conclusions: Paper-based administrations create unnecessary variability around endpoint measurements, which can contribute to inconclusive results. The Virgil eCOA platform with real-time clinical guidance, auto-calculation of scores, and prompts for missing data and out-of-range errors can help standardize scale administration and scoring, thereby substantially reducing error variance and improving signal detection.SATURDAY,