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Assessing the Value of an AI Platform During Screening to Predict Adherence to Study Drug During Treatment in an Ongoing Proof-of-concept Study in Schizophrenia

 

In this poster you will learn: 

  • Non-adherence is a major challenge in clinical trials in psychiatric indications such as schizophrenia. Traditional methods such as pill count and self-report are not deemed sufficiently reliable.
  • Accurate drug adherence data are critically needed to decrease variability and increase signal-to-noise ratio in proof-of-concept studies, which aim to show preliminary evidence of efficacy in a relatively small sample size.
  • We implemented a novel AI platform (AiCure) to monitor adherence to study treatment in an ongoing Phase 2b study of basmisanil, a GABAA  .5 negative allosteric modulator, for the treatment of Cognitive Impairment Associated with Schizophrenia.
  • We implemented a novel “placebo test-phase” during the screening period in which patients has to use the AI platform in order to demonstrate the ability to use the system and adhere to prescribed treatment.