Case Examples: Cogstate Digital Assessments Aid in Critical Safety Decision Making Across Indications
- Cogstate supported the Phase 1, 2-period crossover study of intranasal esketamine to evaluate any potential cognitive effects from the administration of the therapeutic candidate. Subjects were tested using a Cogstate battery of digital assessments multiple times in short succession including at -1 hours, 40 minutes, 2 hours, 4 hours, and 6 hours after dosing. At 40-minutes post-dose there was a significant difference in cognition from placebo, and at 2-hours post-dose no significant difference in cognition was found between groups. This cognitive safety data contributed to the Risk Evaluation and Mitigation Strategy (REMS) of intranasal esketamine.*
- Four Cogstate computerized tests were selected as safety outcomes for the pivotal, international Phase 3 pediatric trial of repatha, a drug to address hypercholesteremia. Cholesterol is important for the brain, so it was important to show the scientific community and regulators that the drug did not cause any problem with thinking. Data demonstrated that the drug reduced cholesterol levels and is safe in its effect on the brain.** Based on the data, the FDA approved the drug for treatment of hypercholesteremia in children aged 10+.
- Cogstate supported safety assessment in a 24-month observational study of natalizumab in multiple sclerosis patients. 63 patients were treated and assessed prior to monthly infusions using a Cogstate battery and the Symbol Digit Modalities Test (SDMT). Using data from the Cogstate assessments, no patient showed evidence of sustained cognitive deterioration over the 24-month period. Data were relevant to ensuring long-term safety and sustained efficacy of treatment.***
*Bahr, R., et al., Pharmacy and Therapeutics, 2019: PMCID: PMC6534172
**R.D. Santos et al., New England Journal of Medicine: DOI 10.1056/NEJMoa2019910
*** Gaudet D., et al., Atherosclerosis, 2021: DOI: https://doi.org/10.1016/j.atherosclerosis.2021.06.789