Measuring the cognitive profile of drugs in Phase I trials is valuable because it can help determine the cognitive safety of a drug early on – allowing researchers to monitor risks in later phases of development. However, despite the benefits of cognitive assessment in Phase I trials, it can be challenging to conduct these studies as the tests have to be brief, have good psychometric properties in small sample sizes and be able to detect changes in healthy volunteers without the risk of ceiling effects.
The aim of this research, presented at ISCTM 2015, was to develop and validate a concise cognitive assessment to enable sensitive measurement of cognitive performance in Phase I clinical trials - with minimal burden to raters and subjects,.
Existing CANTAB cognitive tests were adapted so that they were shorter, more difficult, administered automatically using voiceover instructions, had updated graphics, and were able to run on an iPad hardware system.
A total of 81 healthy individuals aged 19 to 69 years (with years of education ranging from 10 to 25 years) completed the original CANTAB tests and the new Phase I versions of the tests at Training, Baseline and Week 1. The training sessions and baseline were one week apart. All participants completed both versions of the tests at every visit, with the order of version counterbalanced.
Our results demonstrate that the new tests designed for use in Phase I clinical trials have good test-retest properties, both in a large and small samples. The performance assessed using these tests also corresponds well with performance assessed using the established CANTAB technology.
These findings provide support for the value of this technology in Phase I clinical trials, where brevity and sensitivity to impairments in healthy volunteers is important.
Interested in learning more about the development and validation of a concise cognitive assessment for use in Phase 1 clinical trials? Download this poster.