11 January 2023
Assessing Cognitive Safety of Drugs in Clinical Development
In this webinar, Dr Kenton Zavitz, Director of Clinical Affairs discusses assessing cognitive safety of drugs in clinical development.
- Kenton H. Zavitz, PhD, Director of Clinical Affairs
- Pradeep Nathan, PhD, Vice President Neuroscience Scientific Strategy Lead and Head, Neuroscience Center of Innovation, inVentiv Health
Key Discussion Points:
- What is cognition and how is it best measured throughout the drug development process for both CNS and non-CNS indications?
- Why monitor cognition in drug development?
- Are there current or upcoming regulations that impact cognition assessment?
- What are desirable characteristics of cognitive assessment tools?
- What developments are on the horizon for cognitive assessment?
Cognitive impairment is increasingly recognised as a serious potential side effect of medication – both for central nervous system (CNS) and non-CNS compounds. Despite concerns voiced by physicians, regulators and consumers many drug development programs do not incorporate objective and sensitive cognitive assessments as part of the clinical characterization and decision-making process. Additionally, cognitive assessment is an essential tool for clinical trial research professionals for the evaluation of the efficacy of many new medications being developed to address devastating diseases, including Alzheimer’s disease, depression, schizophrenia and ADHD.
Gain a firm understanding of why there is a need to assess cognitive safety in clinical development of compounds, the methodological considerations for cognitive assessment in clinical trials, approaches to the analysis and interpretation of cognitive outcome measures and how current state-of-the-art cognitive assessment technology can be incorporated into the clinical development process to facilitate early decision making, evaluate cognitive efficacy, profile safety and tolerability and satisfy regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape.