Cogstate has supported more than 90 studies of Alzheimer’s disease, spanning the spectrum of disease stages and in all phases of clinical development. Learn more about how we work with study teams to drive new innovations that increase the chance for study success.
Rare and orphan disease research represents the fastest growing area of drug development, but these studies face significant challenges including endpoint selection and measurement. Learn how Cogstate supports the unique challenges of studies in these indications.
Selecting, acquiring and translating the appropriate rating scale instruments for a study is a meticulous process of great consequence. Learn about Cogstate’s experience and partner relationships that enable us to provide superior scale acquisition and management services for clinical trials.
Test selection is a key component of pediatric rare disease clinical trial development. Assessments need to be appropriate for the functioning level of the population and also have adequate sensitivity and specificity to detect change over time in the target population.
Data Quality, Rater Training and Regulatory Expectations: Basic Principles and Good Clinical Practice for CNS Clinical Trials
Clinical outcomes, particularly complex clinician-rated scales, are subject to variability and error due to a myriad of issues, making it less likely that a study will yield reliable, statistically significant results. Robust rater training and certification protocols are suggested to ensure greater standardization and reliability.
Using Cognitive Assessments in Early Clinical Development to Evaluate Drug Effects on the Ability to Operate a Motor Vehicle
Many classes of drugs designed to act on the central nervous system (CNS) may also disrupt cognition. A directly related public health priority is the need to assess the potential of a compound to impair a person’s ability to operate a motor vehicle.