Featured Batteries

Fit-for-purpose batteries to sensitively assess cognitive function in many indications across all phases of clinical research.

Customized Test Batteries for Clinical Trial Decision-Making

Several factors should be considered when selecting a cognitive test battery for a clinical trial. These include an understanding of the context in which the battery is being used, the cognitive effects associated with the disease being studied and the mechanism of action for the treatment under investigation. Subject-level factors such as disease severity and minimizing patient burden are also important considerations.

TALK WITH OUR TEAM ABOUT CUSTOMIZABLE BATTERIES

Measure the Nuanced Cognitive Effects of Different Investigational and Marketed Therapeutics

Customized batteries help you detect and monitor the core cognitive domains impacted by specific diseases and drug mechanisms. The scientific rationale and support for their validity, reliability and sensitivity to drug effects in clinical trials has been detailed in hundreds of peer-reviewed scientific publications.

Watch a 2-minute overview of the Cogstate Brief Battery™

The Cogstate Brief Battery has been used extensively as a rapid and reliable screening assessment in a range of clinical indications, including Alzheimer’s Disease, depression, schizophrenia, AIDS, dementia complex and as a measure of cognitive decline following a mild traumatic brain injury or suspected concussive episode.

Cogstate Batteries

We invite you to explore select examples of batteries tailored to measure the domains of interest for a wide range of therapeutic indications.

Cogstate Brief Battery

A rapid and reliable cognitive screening assessment across indications and phases of development.

The Cogstate Brief Battery™ has been used extensively as a rapid and reliable screening assessment in a range of clinical indications, including Alzheimer’s Disease, depression, schizophrenia, AIDS, dementia complex and as a measure of cognitive decline following a mild traumatic brain injury or suspected concussive episode. The Cogstate Brief Battery has also been used widely in the context of measuring cognitive dysfunction relative to healthy groups in both pediatric and adult populations.

The Cogstate Brief Battery provides a measure of four core cognitive domains: processing speed, attention, visual learning and working memory. Study teams wishing to measure all or a subset of these domains can choose the tests that best suit their specific research questions. Each of the tests have been utilized previously in clinical trials and maintain excellent reliability across repeated testing and cross-sectional research designs. This battery maintains excellent psychometric properties in relation to test-retest reliability. The criterion and 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.

Key References

Lim, Y. Y., Ellis, K. A., Harrington, K., Ames, D., Martins, R. N., Masters, C. L., … Group, T. A. R. (2012). Use of the CogState Brief Battery in the assessment of Alzheimer’s disease related cognitive impairment in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study. J Clin Exp Neuropsychol, 34(4), 345–358.

Lim, Y. Y., Jaeger, J., Harrington, K., Ashwood, T., Ellis, K. a, Stöffler, A., … Maruff, P. (2013). Three-Month Stability of the CogState Brief Battery in Healthy Older Adults, Mild Cognitive Impairment, and Alzheimer’s Disease: Results from the Australian Imaging, Biomarkers, and Lifestyle-Rate of Change Substudy (AIBL-ROCS). Archives of clinical neuropsychology :doi:10.1093/arclin/act021

Maruff, P., Lim, Y. Y., Darby, D., Ellis, K. A., Pietrzak, R. H., Snyder P. J., Bush, A. I., Szoeke, C., Schembri, A., Ames, D., Masters, C. L., & the AIBL Research Group (2013) Clinical utility of the Cogstate brief battery in identifying cognitive impairment in mild cognitive impairment and Alzheimer’s disease. BMC Pharmacology & Toxicology, 1:30

Fredrickson, J., Maruff, P., Woodward, M., Moore, L., Fredrickson, A., Sach, J., Darby, D. (2010) Evaluation of the Usability of a Brief Computerized Cognitive Screening Test in Older People for Epidemiological Studies. Neuroepidemiology, 34: 65-75.

Louey, A. G., Cromer, J. A., Schembri, A. J., Darby, D. G., Maruff, P., Makdissi, M., & Mccrory, P. (2014). Detecting cognitive impairment after concussion: sensitivity of change from baseline and normative data methods using the CogSport/Axon cognitive test battery. Archives of Clinical Neuropsychology, 29(5), 432-441. doi: 10.1093/arclin/acu020

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
Length:Approx. 12-15 minutes
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV; general cognitive screening battery
Culture and Language Neutral:Yes

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Cogstate Schizophrenia Battery

Assess cognitive function in subjects with schizophrenia in both the acute and chronic stages.

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measures the cognitive domains affected by schizophrenia: processing speed, attention, verbal and visual learning, working memory, visual motor function, executive function and social cognition.

Tests can be grouped to match the cognitive domains recommended by the MATRICS group, or smaller groups of tests can be assembled to measure more specific domains. For each test, the construct validity for cognitive impairment in schizophrenia, as well as the sensitivity to change in cognition in schizophrenia has been demonstrated in the scientific literature. The tests have also been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical populations and healthy controls. Study teams wishing to measure all or a subset of these domains can choose the tests that best suit their specific research questions. Each of the tests have been utilized previously in drug trials and maintain excellent reliability across repeated testing and cross-sectional research designs.

Key References

Bartzokis, G., Lu, P. H., Amar, C. P., Raven, E. P., Detore, N. R., Altshuler, L. L., …  Nuechterlein, K. H. (2011). Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory. Schizophrenia Research, 132(1), 35-41. doi: 10.1016/j.schres.2011.06.029

Lieberman, J. A., Dunbar, G., Segreti, A. C., Girgis, R. R.,  Seoane, F., Beaver, J. S.,  Duan, N. & Hosford, D. A., (2013) A Randomized Exploratory Trial of an Alpha-7 Nicotinic Receptor Agonist (TC-5619) for Cognitive Enhancement in Schizophrenia. Neuropsychopharmacology, 38, 968-975.

Pietrzak, R. H., Snyder, P. , J.Maruff, P. (2010)  Use of an acute challenge with d-amphetamine to model cognitive improvement in chronic schizophrenia. Human Psychopharmacology, 25, 353-358.

Preskorn, S. H., Gawryl, M., Dgetluck, N., Palfreyman, M., Bauer, L. O., & Hilt, D. C. (2014). Normalizing effects of EVP-6124, an alpha-7 nicotinic partial agonist, on event-related potentials and cognition: a proof of concept, randomized trial in patients with schizophrenia. Journal of Psychiatric Practice, 20(1), 12–24. doi:10.1097/01.pra.0000442935.15833.c5

Riedel, M., Schmitz, M., Kåre, P., Ferrannini, L., Franco, M. A., Alfano, V., & Dencker, E. (2015). Comparison of the effects of quetiapine extended-release and quetiapine immediate-release on cognitive performance , sedation and patient satisfaction in patients with schizophrenia : A randomised , double-blind , crossover study ( eXtRa ). Schizophrenia Research. doi:10.1016/j.schres.2014.12.027

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
Two Back Test
International Shopping List Test
Groton Maze Learning Test
Social-Emotional Cognition Test (Coming Soon)
Length:Approx. 35 minutes
(if all tests in the battery are selected*)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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Cogstate Pre-Clinical Alzheimer’s Battery

Assess cognitive function in subjects with pre-clinical Alzheimer’s disease.

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measure the cognitive domains affected by mild cognitive impairment and pre-clinical AD: processing speed, attention, visual learning and working memory.

The construct validity of each test for cognitive impairment in pre-clinical AD as well as the sensitivity of these tests to change in cognition has been demonstrated in the scientific literature. The tests have also been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical samples and healthy controls. Study teams wishing to measure all or a subset of these domains can choose the tests that best suit their specific research questions. Each of the tests have been utilized previously in drug trials and maintain excellent reliability across repeated testing and cross-sectional research designs.

Key References

Lim, Y. Y., Maruff, P., Pietrzak, R. H., Ellis, K. A., Darby, D., Ames, D., … Rowe, C. C. (2014). Aβ and cognitive change: Examining the preclinical and prodromal stages of Alzheimer’s disease. Alzheimer’s & Dementia, 10(6), 743-751. doi: http://dx.doi.org/10.1016/j.jalz.2013.11.005

Lim, Y. Y., Villemagne, V. L., Pietrzak, R. H., Ames, D., Ellis, K. A., Harrington, K., … Maruff, P. (2014). APOE ε4 moderates amyloid-related memory decline in preclinical Alzheimer’s disease. Neurobiology of Aging, 11. doi: 10.1016/j.neurobiolaging.2014.12.008

Lim, Y. Y., Ellis, K. A., Harrington, K., Pietrzak, R. H., Gale, J., Ames, D., Bush, A. I., Darby, D., Martins, R. N., Masters, C. L., Rowe, C. C., Savage, G., Szoeke, C., Villemagne, V. L., Maruff P. (2013) Cognitive decline in adults with amnestic mild cognitive impairment and high amyloid-β: prodromal Alzheimer’s disease? Journal of Alzheimer’s Disease: 33 (4); 1167-76

Lim, Y. Y., Maruff, P., Pietrzak, R. H., Ames, D., Ellis, K. a, Harrington, K., … Rowe, C. C. (2014). Effect of amyloid on memory and non-memory decline from preclinical to clinical Alzheimer’s disease. Brain : a journal of neurology, 137(Pt 1), 221–31. doi:10.1093/brain/awt286

Lim, Y. Y., Villemangne, V. L., Laws, S. M., Pietrzak, R. H., Snyder, P. J., Ames, D., … Maruff, P. (2014). APOE and BDNF polymorphisms moderate amyloid β-related cognitive decline in preclinical Alzheimer’s disease. Molecular Psychiatry. doi: 10.1038/mp.2014.123

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
Length:Between 5-15 minutes
(depending on the number of tests included in the battery*)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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Cogstate Alzheimer's Battery

Assess cognitive function in adults with mild cognitive impairment (MCI) and clinically-diagnosed Alzheimer’s disease (AD).

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tasks measures the cognitive domains affected by MCI and AD, namely processing speed, attention, verbal and visual learning, working memory, visual motor and executive function.

The construct validity of each test for cognitive impairment in MCI and AD as well as the sensitivity of these tests to change in cognition has been demonstrated in the scientific literature. The tests have also been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical samples and healthy controls. Study teams wishing to measure all or a subset of these domains can choose the tests that best suit their specific research questions. Each of the tests have been utilized previously in drug trials and maintain excellent reliability across repeated testing and cross-sectional research designs.

Key References

Darby, D. G., Pietrzak, R. H., Fredrickson, J., Woodward, M., Moore, L., Fredrickson, A., … Maruff, P. (2012). Intraindividual cognitive decline using a brief computerized cognitive screening test. Alzheimer’s and Dementia, 8(2), 95–104. doi:10.1016/j.jalz.2010.12.009

De Jager, C. a, Schrijnemaekers, A.-C. M. C., Honey, T. E. M., & Budge, M. M. (2009). Detection of MCI in the clinic: evaluation of the sensitivity and specificity of a computerised test battery, the Hopkins Verbal Learning Test and the MMSE. Age and ageing, 38(4), 455–60. doi:10.1093/ageing/afp068

Hammers, D., Spurgeon, E., Ryan, K., Persad, C., Barbas, N., Heidebrink, J., … Giordani, B. (2012). Validity of a brief computerized cognitive screening test in dementia. J Geriatric Psychiatry Neurology, 25(2), 89–99. doi:10.1177/0891988712447894.

Hammers, D., Spurgeon, E., Ryan, K., Persad, C., Heidebrink, J., Barbas, N., Albin, R., Frey, K., Darby , D., and Giordani, B. (2011) Reliability of Repeated Cognitive Assessment of Dementia Using a Brief Computerized Battery. American Journal of Alzheimer’s Disease and Other Dementia’s: 26 (4) 326-333.

Lim, Y. Y., Ellis, K. A., Harrington, K., Ames, D., Martins, R. N., Masters, C. L., … Group, T. A. R. (2012). Use of the CogState Brief Battery in the assessment of Alzheimer’s disease related cognitive impairment in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study. Journal of Clinical and Experimental Neuropsychology, 34(4), 345–358. doi:10.1080/13803395.2011.643227

Lim, Y. Y., Ellis, K. A., Pietrzak, R. H., Ames, D., Darby, D., Harrington, K., … the AIBL Research Group, F. (2012). Stronger effect of amyloid load than APOE genotype on cognitive decline in healthy older adults. Neurology, 79(16), 1645–1652. doi:10.1212/WNL.0b013e31826e9ae6

Lim, Y. Y., Ellis, K. A., Ames, D., Darby, D., Harrington, K., Martins, R. N., … Group, A. R. (2012). Aβ amyloid, cognition, and APOE genotype in healthy older adults. Alzheimers Dementia. doi:10.1016/j.jalz.2012.07.004

Lim, Y. Y., Jaeger, J., Harrington, K., Ashwood, T., Ellis, K. A., Stoffler, A., … Maruff, P. (2013). Three-month stability of the CogState brief battery in healthy older adults, mild cognitive impairment, and Alzheimer’s disease: results from the Australian Imaging, Biomarkers, and Lifestyle-rate of change substudy (AIBL-ROCS). Archives of Clinical Neuropsychology, 28(4), 320-330. doi: 10.1093/arclin/act021

Maruff, P.,  Lim, Y. Y., Darby, D., Ellis, K. A., Pietrzak, R. H., Snyder P. J., Bush, A. I., Szoeke, C., Schembri, A., Ames, D., Masters, C. L., & the AIBL Research Group (2013). Clinical utility of the Cogstate brief battery in identifying cognitive impairment in mild cognitive impairment and Alzheimer’s disease. BMC Pharmacology & Toxicology, 1:30

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
International Shopping List Test
International Shopping List Test - Delayed Recall
Continuous Paired Associate Learning Test
Modified Groton Maze Learning Test
Length:Between 5-30 minutes
(depending on the number of tests included in the battery*)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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Cogstate Brain Injury Battery

Assess cognitive function in subjects with concussion and Traumatic Brain Injury (TBI).

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measure the cognitive domains affected by concussion and TBI, namely processing speed, attention, visual learning, working memory, visual motor function and executive function.

The construct validity of each test for cognitive impairment in concussion and TBI as well as the sensitivity of these tests to change in cognition has been demonstrated in the scientific literature. The tests have also been shown to be valid for use in professional athletes, different cultures and different language groups, with comparative/normative data available for both clinical samples and healthy controls. Study teams wishing to measure all or a subset of these domains can choose the tests that best suit their specific research questions. Each of the tests maintains excellent reliability across repeated testing and cross-sectional research designs.

Key References

Cole, W. R., Arrieux, J. P., Schwab, K., Ivins, B. J., Qashu, F. M., and Lewis,  S. C. (2013). Test–Retest Reliability of Four Computerized Neurocognitive Assessment Tools in an Active Duty Military Population.  Archives of Clinical Neuropsychology: 28 (7), 732 – 42.

Eckner, J.T , Kutcher, J. S.,  Richardson, J. K., (2011). Between-Seasons Test-Retest Reliability of Clinically Measured  Reaction Time in National Collegiate Athletic  Association Division I Athletes. Journal of Athletic Training; 46 (4); 409-414.

Eckner, J. T.,  Kutcher, J. S.,  Richardson J. K., (2011). Effect of Concussion on Clinically Measured Reaction Time in 9 NCAA Division I Collegiate Athletes: A Preliminary Study. Physical Medicine and Rehabilitation, 3, 212-218.

Louey, A. G., Cromer, J. A., Schembri, A. J., Darby, D. G., Maruff, P., Makdissi, M., & Mccrory, P. (2014). Detecting cognitive impairment after concussion: sensitivity of change from baseline and normative data methods using the CogSport/Axon cognitive test battery. Archives of Clinical Neuropsychology, 29(5), 432-441. doi: 10.1093/arclin/acu020

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
Groton Maze Learning Test
Length:Between 5-20 minutes
(depending on the number of tests included in the battery*)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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Cogstate Depression Battery

Assess cognitive function in subjects with clinically diagnosed Major Depressive Disorder (MDD).

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measure the cognitive domains affected by MDD: processing speed, attention, visual learning, working memory, visual motor function and executive function.

The construct validity of each test for cognitive impairment in MDD as well as the sensitivity of these test to change in cognition has been demonstrated in the scientific literature. The tests have also been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical samples and healthy controls. Study teams wishing to measure all or a subset of these domains can choose the tests that best suit their specific research questions. Each of the tests have been utilized previously in drug trials and maintain excellent reliability across repeated testing and cross-sectional research designs.

Key References

McIntyre, R. S., Lophaven, S., Olsen, C. K. (2014). A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. International Journal of Neuropsychopharmacology, 17(10), 1557-1567. doi: 10.1017/S1461145714000546.

Olver, J. S., Ignatiadis, S., Maruff, P., Burrows, G. D., and Norman, T. R., (2008) Quetiapine augmentation in depressed patients with partial response to antidepressants. Human  Psychopharmacology Clinical and Experimental; 23: 653–660.

Shiroma, P.R., Albott, C.S., Johns, B., Thuras, P., Wels, J., & Lim, K. O. (2014). Neurocognitive performance and serial intravenous subanesthetic ketamine in treatment-resistant depression. International Journal of Neuropsychopharmacology, 17(11), 1805-1813. doi: 10.1017/S1461145714001011

Yoshida, T., Ishikawa, M., Niitsu, T., Nakazato, M., Watanabe, H., Shiraishi, T., … Hashimoto, K. (2012). Decreased serum levels of mature brain-derived neurotrophic factor (BDNF), but not its precursor proBDNF, in patients with major depressive disorder. PLoS One, 7(8). doi: 10.1371/journal.pone.0042676

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
Groton Maze Learning Test
Length:Between 5-20 minutes
(depending on the number of tests included in the battery*)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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Cogstate Multiple Sclerosis Battery

Assess cognitive function in subjects with Multiple Sclerosis (MS).

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measure the cognitive domains affected by MS: processing speed, attention, verbal and visual learning, working memory, visual motor function and executive function.

Each cognitive test has been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical samples and healthy controls. Study teams wishing to measure all or a subset of these domains can choose the tests that best suit their specific research questions. Each of the tests have been utilized previously in drug trials and maintain excellent reliability across repeated testing and cross-sectional research designs.

Key References

Shaw, M., Clayton, A., Krupp, L., & Charvet, L. (2018). Computerized Measurement of Processing Speed Predicts Cognitive Decline in Pediatric Onset Multiple Sclerosis. Neurology, 90(15 Supplement), P4. 351.

Schwartzbach, C. J., Grove, R. A., Brown, R., Tompson, D., Bergh, F. T., & Arnold, D. L. (2017). Lesion remyelinating activity of GSK239512 versus placebo in patients with relapsing-remitting multiple sclerosis: a randomised, single-blind, phase II study. Journal of Neurology, 264(2), 304-315.

Frontario, A., Schwarz, C., Kasschau, M., Chan, J., Harel, B., Schembri, A., … & Charvet, L. (2015). Cognition in MS across the Lifespan. Neurology, 84(14 Supplement), P5. 194.

Charvet, L., Shaw, M., Frontario, A., Langdon, D., & Krupp, L. (2017). Cognitive impairment in pediatric-onset multiple sclerosis is detected by the Brief International Cognitive Assessment for Multiple Sclerosis and computerized cognitive testing. Multiple Sclerosis Journal, 135245851770158. http://dx.doi.org/10.1177/1352458517701588

Jacques, F. H., Harel, B. T., Schembri, A. J., Paquette, C., Bilodeau, B., Kalinowski, P., & Roy, R. (2016). Cognitive evolution in natalizumab-treated multiple sclerosis patients. Multiple Sclerosis Journal–Experimental, Translational and Clinical, 2, 1-6.

Wojcik, C., Rao, S., Schembri, A., Drake, A., Maruff, P., Schindler, D., … Weinstock-Guttman, B. (2020). Necessity of technicians for computerized neuropsychological assessment devices in multiple sclerosis. Multiple Sclerosis Journal, 26(1), 109–113. https://doi.org/10.1177/1352458518813287

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
Two Back Test
International Shopping List Test
Groton Maze Learning Test
Length:Between 5-40 minutes
(depending on the number of tests included in the battery*)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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Cogstate Safety 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.

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.

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
Groton Maze Learning Test
Length:Approx. 15 minutes
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I
Culture and Language Neutral:Yes

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Cogstate Pediatric Safety Battery

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

The Cogstate pediatric safety battery has been used extensively in academic studies and 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 obtain 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. The pediatric-specific safety battery has been designed for subjects as young as four years of age and can be administered to healthy and clinical populations throughout childhood, adolescence and into adulthood. The battery can be used to measure cognitive impairment relative to normative data or developmental trajectories in the context of studies with a longer duration.

The Cogstate pediatric safety battery has been designed specifically for administration to children, with child-friendly instructions and stimuli being presented throughout. The battery is brief and has demonstrated that repeated measurement does not give rise to practice effects. Hence this 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. Cogstate’s computerized pediatric safety battery measures the cognitive domains of processing speed, attention, visual learning and executive function. The construct validity of each task for cognitive impairment as well as the sensitivity of these tasks to change in cognition has been demonstrated in the scientific literature in both child and adolescent populations, and each task has also been shown to be valid for use in different cultures and language groups.

Key References

Antinew, J., Pitrosky, B., Knapp, L., Almas, M., Pitman, V., Liu, J.,…& Farkas, K. (2019).
Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. Journal of Child Neurology, 34(5), 248-255.

Bredlau, A. L., Harel, B. T., McDermott, M. P., Dworkin, R. H., Korones, D. N., Dolan, J. G., & Adams, H. R. (2015). Neurocognitive changes after sustained ketamine administration in children with chronic pain. Journal of Palliative Care & Medicine, 5(2).

Cogstate Tests:Pediatric Detection Test
Pediatric Identification Test
Pediatric One Card Learning Test
Modified Groton Maze Learning Test
Length:Approx. 15 minutes
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I
Culture and Language Neutral:Yes

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Cogstate Epilepsy Battery

Assess cognitive function in pediatric and adult subjects with epilepsy and associated seizure disorders.

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measure the cognitive domains affected by epilepsy, namely areas of processing speed, attention, memory and executive function.

The Cogstate epilepsy battery has been validated among both pediatric and adult seizure disorder populations and can be utilized in early and later Phase clinical trials with brief or longer-term retest intervals without practice effects. This battery is available both in the context of evaluating a safety profile or assessing the efficacy of a study drug and can be tailored to meet the needs of a study, depending on the nature of the seizure disorder population under investigation and the cognitive domains of greatest interest to the study team. The battery has been designed to evaluate sedative aspects commonly of interest in epilepsy and the relationships between performance on the tests and associated subjective measures (i.e., QoL), mood or side effect profiles. Each test has been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical samples and healthy controls.

Key References

Meador, K., Kanner, A., Morrision, C., Schembri, A., Hesdorffer, D., O’Brien, T., … & Winawer, M. (2017). Relationship between Cognitive Performance and Subjective Symptoms in Patients with Newly Diagnosed Focal Epilepsy (S21. 003). Neurology, 88(16 Supplement), S21-003.

Antinew, J., Pitrosky, B., Knapp, L., Almas, M., Pitman, V., Liu, J.,…& Farkas, K. (2019).
Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. Journal of Child Neurology, 34(5), 248-255.

Cogstate Tests:Detection Test
Identification Test
International Shopping List Test
One Back Test
Groton Maze Learning Test
Length:Approx. 20 minutes
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I
Culture and Language Neutral:Yes

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Cogstate Oncology Battery

Assess cognitive function in pediatric and adult subjects to study the effects of cancer and anti-cancer drugs.

Cogstate’s computerized battery of rapid, reliable, simple and sensitive tests measure the cognitive domains affected by various types of cancer, namely areas of attention, memory and executive function.

The validity of the Cogstate battery in oncology settings has been reported in the academic literature, with studies showing high acceptability and tolerability in patients with brain tumor, glioblastoma, brain metastases, metastatic melanoma, breast cancer, and men with testicular or prostate cancer. Cogstate tests have demonstrated excellent sensitivity to the cognitive impairment that occurs in oncology patients receiving a range of treatments including radiation and chemotherapy, and identification of clinically meaningful change over longitudinal assessments have been reported in response to both pharmacological or psychological therapies. Acute cognitive changes have been demonstrated in clinical trials in patients with brain metastases, breast cancer and Acute Lymphoblastic Leukemia (ALL), whilst relationships between the Cogstate tests and conventional neuropsychological and clinical rating scales in oncology have been established in pediatric and adult contexts.

Key References

Caine, J., Mehta, M., Deshmukh, S., Gondi, V., Tome, W., Kanner, A., … Kachnic, L. (2014). CogState computerized memory tests in patients with brain metastases: Secondary endpoint results of RTOG 0933. Radiotherapy and Oncology, 111, S5.

Patel, S., Meier, A., Fernandez, N., Lo, T., Moore, C., & Delgado, N. (2017). Convergent and criterion validity of the CogState computerized brief battery cognitive assessment in women with and without breast cancer. The Clinical Neuropsychologist, 1-12. http://dx.doi.org/10.1080/13854046.2016.1275819

Phillips, K.-A., Ribi, K., Sun, Z., Stephens, A., Thompson, A., Harvey, V., … Bernhard, J. (2010). Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial. Breast (Edinburgh, Scotland), 19(5), 388–95. http://doi.org/10.1016/j.breast.2010.03.025

Rogiers, A., Leys, C., De Cremer, J., Awada, G., Schembri, A., … & Neyns, B. (2019). Health-related quality of life, emotional burden, and neurocognitive function in the first generation of metastatic melanoma survivors treated with pembrolizumab: a longitudinal pilot study. Supportive Care in Cancer. https://doi.org/10.1007/s00520-019-05168-3

Sands, S. A., Harel, B. T., Savone, M., Kelly, K., Vijayanathan, V., Welch, J. G., … & Cole, P. D. (2017). Feasibility and baseline neurocognitive assessment using Cogstate during the first month of therapy for childhood leukemia. Support Care Cancer, 25, 449-457.

Cogstate Tests - Adult:Detection Test
Identification Test
International Shopping List Test
One Back Test
Cogstate Tests - Pediatric:Detection Test
Identification Test
One Card Learning
One Back Test
Groton Maze Learning Test
Length:Approx. 20 minutes
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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