Cognitive Safety

Performance on cognitive tests can provide a sensitive assessment of the impact of a drug on the central nervous system (CNS). Cogstate helps sponsors assess cognitive safety in all stages of drug development and across indications via our brief and reliable computerized cognitive testing.

Using cognitive testing for safety/tolerability in early trials provides insights into maximum tolerated dose and the duration and severity of any adverse effects. In later development stages and post-approval, cognitive assessment can be informative as to the presence of deleterious effects in the context of long-term follow-up, and in larger, more representative samples.


The Need for Safety Evaluations 

The FDA have long recognized the potential of drugs to cause cognitive impairment and for effects on cognition to be an important guide to safety and tolerability, and that self-report may be inadequate. Inclusion of targeted, objective cognitive assessments helps study teams make informed decision on cognitive safety of an experimental therapeutic.

Make Informed Cognitive Safety Decisions via Digital Assessments 

Using safety assessment to gather data on potential adverse cognitive effects can inform important elements such as dose-response relationships, differentiation from competitor drugs, and detection of off-target pharmacological effects. Cognitive safety assessments can provide different information at different stages of drug development. Short term studies such as SAD, MAD, drug-drug, and drug-alcohol interaction need different approaches than longer-term studies such as disease management and cognitive development in children.

Cogstate’s team of scientists have the expertise to advise your team on the strategic and appropriate use of digital cognitive assessments as safety measures. Cogstate solutions can help your team approach trials with reduced risk.

Leverage Sensitive and Reliable Digital Tests 

Cogstate digital assessments provide rapid and reliable measurement of distinct cognitive domains and enable you to capture a complete and nuanced picture of a subject’s cognitive state.

Cogstate tests are culture- and education-neutral and designed for repeated administration with minimal practice or learning effects, making them ideal for use in global clinical trials. Normative data is available for both clinical samples and healthy controls. Study teams can choose the tests that best suit their research questions. Each test has been used in drug trials.

More on Digital Assessments

Sample Safety Battery 

The tests included are a sample battery based on domains commonly assessed for safety. Final battery recommendations vary based on study needs.

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

Cogstate Digital Tests Aid in Critical Safety Decision Making Across Indications

Crossover study of intranasal esketamine

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. (Bahr, R., et al., Pharmacy and Therapeutics, 2019: PMCID: PMC6534172)

International Phase 3 pediatric trial of repatha

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+ (R.D. Santos et al., New England Journal of Medicine: DOI 10.1056/NEJMoa2019910)

Cognitive safety concern around sacubitril/valsartan

A cognitive safety concern existed around sacubitril/valsartan, a compound taken by heart failure patients with preserved ejection fraction. The PERSPECTIVE trial (NCT02884206) leveraged seven Cogstate digital tests to assess 592 patients with heart failure. Participants took cognitive assessments every six months over 3 years. Data presented at the European Society of Cardiology showed cognitive function did not change, indicating the cognitive safety of sacubitril/valsartan.

24-month observational study of natalizumab in multiple sclerosis patients

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. (Gaudet D., et al,  Atherosclerosis, 2021: DOI:

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