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Using an Artificial Intelligence Platform on Mobile Devices to Monitor and Increase Adherence in Subjects With Schizophrenia


In this poster you will learn: 

  • The need to ensure optimal adherence is critical in all clinical trials, particularly in ambulatory subjects. To date, most clinical trials have relied on scheduled pill counts and self-reported data to monitor drug compliance, even though these data are unreliable and tend to overestimate adherence. Pill counts routinely indicate levels of adherence above 95% across therapeutic areas.
  • One alternative has been measurement of concentrations of a drug or its metabolite; however, between-person variability in pharmacokinetics (PK) and limits on the frequency of blood sampling prevent this approach from providing accurate day-to-day information on adherence. Equally, results from PK sampling would come in too late for any intervention.
  • The artificial intelligence (AI) platform (AiCure, New York, NY) uses software algorithms on smartphones to visually and automatically confirm participant identity, the medication, and medication ingestion. Participants receive automated reminders and precise dosing instructions. Study teams have access to real-time data for review and intervention.
  • A phase 1b study, randomized, double-blind, cross-over trial ( identifier NCT02824055) was recently completed in the United States that evaluated the efficacy, safety, and tolerability of treatment for 9 weeks (three 3-week treatment courses) with RO5545965 compared with placebo in subjects with schizophrenia.