Predict the placebo response. De-risk Phase III.
In CNS and psychiatric trials, placebo response rates are among the highest of any therapeutic area — frequently eroding treatment effect to the point where genuinely efficacious drugs fail to separate. AI-COPE measures the placebo response as a true psychobiological phenomenon, live, from the patient–clinician interaction itself.
Placebo response is a billion-dollar measurement problem.
The financial consequences span two failure modes: inflated trial budgets driven by larger sample sizes, and outright Phase III failure — the most catastrophic outcome in drug development.
Three steps. No new scales.
AI-COPE produces a Live Placebo Responsiveness Score (LPRS) per patient. The score enters the analysis as a pre-specified ANCOVA covariate, dramatically reducing variance and improving detection of true treatment efficacy — with no risk to data analysis or study conduct.
Assess
Baseline patient psychology and expectation are extracted from the standard doctor-patient interview — no new instruments required.
Predict
Agentic models combine baseline behavioral signals with comorbidity and disease-intensity data to score individual placebo responsiveness.
Update
Wearable signals and brief automated check-ins update the LPRS over the trial. The score enters analysis as a pre-specified covariate.
AI-COPE can be incorporated into any clinical trial regardless of size, design, or context — including decentralized and virtual trials.
ISTAND DDT. Built for qualification.
We are preparing a Letter of Intent for the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Drug Development Tool pathway — designed for transformational technologies that augment, rather than replace, established endpoints.
Run AI-COPE in your next trial.
Pre-IND consultations, ISTAND DDT collaboration, direct sponsor engagements, or retrospective re-analysis of completed studies — we're ready to talk.