There are several intriguing aspects of the trial design that may have gone unnoticed but that should provide the trial with the best possible opportunity to distinguish the placebo effect from the treatment effect.
1) This is expected to be the most consistently accurate CDR trial ever conducted. It is the first to utilize Cambridge Cognition's (Winterlight Labs) new AQUA Voice AI quality control system for scales and rater training products. This technology provides immediate and standardized objective scoring and feedback on every rater sessions conducted. Traditionally, quality control efforts have pulled a low number of rater sessions at random which are manually reviewed and often only after a significant delay. In this trial the variability among raters, individual sessions, and sites should be considerably lower when compared to typical CDR endpoint trials, with issues being flagged immediately to prevent compounding. Less noise more signal.
2) They are using CANTAB as a secondary endpoint, and although it is not explicitly stated, the number of digital tests they are administering suggests it is the full battery. This is notable because CANTAB has been employed in many trials examining the effects of cortisol on conditions ranging from depression and sleep to anxiety and PTSD. While this is not directly confirmed, utilizing the full CANTAB battery alongside the cortisol datasets from Cambridge Cognition may provide deeper insights into the placebo and treatment effects observed in the primary endpoint. Additionally, there is a possibility that a specific combination of tests may help identify patients with a better prospect for a treatment response. This appears to have been a very deliberate and specific decision in the trial design, as Cogstate was used for the MDD trial and they would have been the straightforward and obvious choice for this technology for this trial, considering their dominant position in the AD trials market.
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