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. Therefore, it is important to assess the safety and tolerability of drugs in the early phases of development and consider the potential for adverse cognitive effects.

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. As described in a 2017 FDA Guidance for industry, driving is a complex activity involving cognitive, perceptual and motor functions. Impairment of these functions raise important safety concerns related to driving and the operation of heavy machinery and it is important to carefully evaluate tests for this potential impact when developing CNS compounds.

Cogstate’s early phase computerized battery is a valid and reliable measure of functions relevant for driving ability, providing both sensitive and clinically relevant assessment in this context.

Download the whitepaper below to learn more about measuring functions related to driving impairment.

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