CNS Active Compounds ― The Importance Of Cognitive And Pharmacodynamic Testing During First-In-Human Trials

This presentation provides a detailed overview of cognitive and pharmacodynamic (PD) testing in first-in-human (FIH) trials for CNS-active drugs. These assessments are essential for understanding a compound’s central nervous system profile, offering early insights into both safety and proof-of-concept.

Cognitive and PD testing helps identify key risks such as impairment, abuse potential, and suicidality. Early detection of these effects can clarify which regulatory requirements must be met and which may be waived, as well as inform target labeling and future clinical trial design. In addition to safety insights, these measures can serve as early indicators of efficacy.

The selection of appropriate testing methods and study populations—whether healthy volunteers or small groups of the target patient population—is critical for generating meaningful, interpretable results. The session will highlight commonly used cognitive and PD test batteries, discussing their applications and limitations in early-stage clinical research.

Attendees will learn how to determine which tests are appropriate, which populations are most valid for assessment, and how these data can guide broader drug development and regulatory strategies. This content is particularly valuable for professionals in pharmaceutical and biotech companies developing CNS-active therapeutics.

Presenters include Dr. Beatrice Setnik (Chief Scientific Officer, Altasciences), Dr. Denise Milovan (Senior Neuroscientist and Neuropsychologist, Altasciences), and Dr. Francesca Cormack (Chief Scientist, Cambridge Cognition).