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Akili Interactive announced Monday top-line results of the STARS-ADHD trial, which revealed that its investigational digital medicine, AKL-T01, showed an improvement in attention in children and adolescents with paediatric attention-deficit hyperactivity disorder (ADHD), achieving the study's primary goal. Based on the results, Akili said that it plans to file AKL-T01 with the FDA, seeking clearance as a novel treatment for children and adolescents with ADHD.
The STARS-ADHD study included 348 participants, aged eight years to 12 years, with ADHD, who were randomised to AKL-T01 or an active control, both which were used at home on a mobile tablet device for four weeks. An assessment was then carried out to measure changes from baseline on standard measures of attention, memory and impulsivity. The study's primary endpoint was change in the Attention Performance Index (API), a composite score from the Test of Variables of Attention that measures sustained attention and inhibitory control.
The results suggested that AKL-T01 showed significant improvement on API compared to no improvement in the control group. Additionally, AKL-T01 was shown to be safe, with no serious adverse events observed and 11 treatment-related adverse events reported in the AKL-T01 group, primarily headache and frustration.
The company explained that AKL-T01 is built on Akili’s Project: EVO technology platform that enables selective targeting and activation of specific cognitive neural systems in the brain that exhibit deficiencies from various medical conditions. AKL-T01 "uses adaptive algorithms to deliver the presentation of stimuli that engage targeted neural systems in the prefrontal cortex." Akili said "in a closed-loop system, the adaptive algorithms automatically adjust the level – or dose – for a personalised treatment experience that is tailored to the needs of each individual patient," adding that "rather than being administered through a pill, AKL-T01 is delivered through a creative and immersive action video game experience."
Scott Kollins, principal investigator, said "the objective improvements of attention observed in the study suggest that AKL-T01 addresses a key deficiency in ADHD that is not directly targeted by standard treatments." Kollins added that "since the active control group in this study also played an engaging video game, we are encouraged that the statistically significant group differences were driven by the therapeutically active component in AKL-T01 and not just the video game experience."
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