New data demonstrates effectiveness of AQUA

Cambridge Cognition, a leading technology company specialising in digital health products that advance brain health research and treatment, announces the recent presentation of new data demonstrating the effectiveness of the Company's Automated Quality Assurance product, ("AQUA").

Central nervous system ("CNS") clinical trials often depend on rater-administered assessments, like Clinical Dementia Rating ("CDR") and Alzheimer's Disease Assessment Scale-Cognitive Subscale ("ADAS-Cog"), as key endpoints. Unlike quantitative biomarkers, which have clear, measurable values, these outcomes are subjective and can be affected by the rater's judgment, training and motivations1,2. Without proper training, even experienced clinicians often disagree on scoring leading to frequent errors3.

Traditional quality assurance for clinical outcome assessments ("COAs") relies on expert raters who must be trained prior to administering the tasks. Cambridge Cognition is confident that, given the lack of standardisation, the heavy utilisation on manual quality control and the high cost and time burden, there is an urgent need for a scalable, cost-effective alternative to enhance measurement accuracy and reduce variability.

Cambridge Cognition launched its proprietary product in 2023. AQUA analyses the audio recording of CNS clinical interviews and detects deviations in administration and scoring by the rater.

Dr Rachel Newsome, Product Manager at Cambridge Cognition recently presented new data4 at the International Society for CNS Clinical Trials and Methodology ("ISCTM") conference. AQUA demonstrated strong alignment with expert reviewers on key quality indicators of CDR recordings in an Alzheimer's disease trial, showcasing its ability to enhance COA review processes and offers an efficient solution to support central monitoring.

Cambridge Cognition believes that AQUA provides a scalable solution, which marks a significant advancement in improving quality assurance for CNS clinical trials

Dr Rachel Newsome, Product Manager commented: "We are excited by the reception that our new data received at the prestigious ISCTM conference. Our innovative quality review solution accelerates quality reviews, improves consistency by reviewing 100% of assessments in a trial, and significantly reduces costs, which ultimately helps clinical trials to succeed."

Dr Steven Powell, Chair of Cambridge Cognition, added: "We are encouraged by the progress of the AQUA product and we are confident that it can meet the clear market need to implement automated processes within quality control in clinical trials."

• Kobak KA, Kane JM, Thase ME, Nierenberg AA. Why do clinical trials fail? The problem of measurement error in clinical trials: Time to test new paradigms? J Clin Psychopharmacol. 2007;27(1):1-5.
• Walton MK, Powers JH 3rd, Hobart J, Patrick D, Marquis P, Vamvakas S, et al. Clinical outcome assessments: Conceptual foundation-report of the ispor clinical outcomes assessment - emerging good practices for outcomes research task force. Value Health. 2015,18(6):741-52.
• Wilson JT, Slieker FJ, Legrand V, Murray G, Stocchetti N, Maas AI. Observer variation in the assessment of outcome in traumatic brain injury: Experience from a multicenter, international randomized clinical trial. Neurosurgery. 2007;61(1):123-8.
• Newsome, RN, Analytical validation of a novel quality assurance approach for COAs in Alzheimer's Disease clinical trials, CNS Clinical Trials and Methodology (ISCTM), 12-13 September 2024, San Diego CA Poster Presentation

Rachel joined Winterlight Labs in 2021 as a Product Manager for the speech data collection application. Following the company's acquisition by Cambridge Cognition in 2023, she now contributes to the voice analytics product and AQUA, the core tool behind Cambridge Cognition's central monitoring solutions.

Rachel received her PhD in Cognitive Neuroscience from the University of Toronto, focusing on memory and perception in amnesia and dementia. She completed a postdoctoral fellowship at the Rotman Research Institute, where she researched learning processes following stroke and brain injury, employing neuroimaging and cognitive experiments to explore how these patients can acquire new information.