Cogstate Early Phase Battery

Demonstrate the cognitive safety profile of compounds in early phase clinical trials.

The Cogstate early phase battery has been used extensively in Phase I research to determine the extent to which treatment with different doses of experimental compounds is associated with changes in cognitive function. Sponsors can get an earlier understanding of how the safety profile of their compound compares to the standard of care or to detect cognitive decline caused by a compound or dosing level before costly late phase trials are initiated.

Tight timelines with strict measurement regimens are a hallmark of early phase research. To address this, the Cogstate early phase battery is brief and has demonstrated that repeated measurement does not give rise to practice effects.  Hence the Cogstate battery can be applied repeatedly in the same individuals under different treatment conditions and the data generated can be used in pharmacokinetic/pharmacodynamics models, or in comparisons between treatment conditions to guide decisions about the safety or efficacy of the medicines studied.  Because the tests in the Cogstate early phase battery have also been used extensively in clinical studies, there exists a large database of treatment effects and their magnitudes that can be used to assist researchers in interpretation of their results.  Furthermore data generated in early phase studies can be considered against performance on the same tests in Phase II and Phase III studies of neurological and psychiatric disorders.

Cogstate’s computerized early phase battery measures the cognitive domains of processing speed, attention, visual learning and executive function. The construct validity of each test for cognitive impairment as well as the sensitivity of these tests to change in cognition has been demonstrated in the scientific literature, and each test has also been shown to be valid for use in different cultures and language groups.

Cogstate Tests

Detection Test

The Detection test measures processing speed using a simple reaction time paradigm.

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Identification Test

The Identification test measures attention using a choice reaction time paradigm.

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One Card Learning Test

The One Card Learning test measures visual memory using a pattern separation paradigm.

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Groton Maze Learning Test

The Groton Maze Learning Test measures executive function using a maze learning paradigm.

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Battery Details

Length:Approx. 15 minutes
Data Processing and Scoring:Automated
Application:Phase I
Culture and Language Neutral:Yes

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Key References

Collie, A., Maruff, P., Snyder, P. J., Darekar, A., & Huggins, J. P. (2006). Cognitive testing in early phase clinical trials: Outcome according to adverse event profile in a Phase I study. Human Psychopharmacology, 21, 481-488.

Collie, A., Darkar, A., Weissgerber, G., Toh, M. K., Snyder, P. J., Maruff, P., & Huggins, J. P. (2007). Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study. Contemporary Clinical Trials, 28, 391-400.