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Evaluating the Use of an Artificial Intelligence Platform on Mobile Devices to Measure Adherence in Subjects With an Acute Exacerbation of Schizophrenia

 

In this poster you will learn:

  • Average medication non-adherence rates range from 20% to 89% among adults with schizophrenia.
  • Select studies in schizophrenia have focused on the use of mobile technologies, particularly around patient self-assessment and the value of psychoeducational tools. Early results are promising even in symptomatic patients.
  • Accurately monitoring and collecting drug adherence data can allow for a better understanding and interpretation of the outcomes of clinical trials. The majority of clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. Pill counts have frequently been shown to underestimate poor adherence and nonadherence.
  • Because of its ability to ensure treatment adherence, directly observed therapy (DOT) has been used for decades to both measure and maximize adherence for treatment of tuberculosis infection and antiretroviral therapy and to ensure ingestion in inpatient settings or in early-phase clinical trials when subjects are dosed in the clinic. However, for trials conducted in outpatient populations, the cost and logistical complexity of administering DOT forces clinical trials to switch to less intensive monitoring despite the continued and largely unmeasured risk of nonadherence.
  • The artificial intelligence (AI) platform (AiCure, New York, NY) uses artificial intelligence to visually confirm medication ingestion using software that can be downloaded as an application onto any mobile device. Software algorithms identify the subject and the drug, and confirm ingestion. Encrypted data are sent to cloud-based dashboards for real-time monitoring and intervention, with suspicious activity, duplicate enrollment, or incorrect usage triggering alerts.
  • A recent Phase 2 study (NCT02477020) was completed in the United States, evaluating the efficacy, safety, and tolerability of treatment for 6 weeks with TAK-063 compared with placebo in subjects with acutely exacerbated schizophrenia. TAK-063 is a potent and selective inhibitor of PDE10A in development for the treatment of schizophrenia. Study subjects were in-hospital for the first 3 weeks of the study and eligible to be discharged after that. The decision to discharge a subject was up to the study investigator. Clinically stable subjects were discharged to the outpatient portion of the study and followed using the AiCure application on a mobile device for the remainder of the 6-week treatment period. A sub-study from this Phase 2 clinical trial provided an opportunity to investigate study drug compliance in subjects discharged from the hospital and followed in the outpatient portion of the study using the AiCure platform.