An investigational digital medicine, AKL-T01, has shown significant improvement compared with a control for pediatric attention-deficit/hyperactivity disorder (ADHD).
In the randomized, controlled trial of 348 children and adolescents diagnosed with ADHD, AKL-T01 showed a statistically significant improvement in its predefined primary efficacy end point, which was a change in the Attention Performance Index.
Patients were evaluated before and after 4 weeks of at-home treatment with either AKL-T01 or an active control, which was designed and tested to have a similar level of expectation of benefits and engagement.
AKL-T01 (Akili Interactive) uses algorithms to deliver a “video game-like” presentation of stimuli that engage targeted neural systems in the prefrontal cortex. The treatment mimics a high-end video game, leveraging art, music, storytelling, and reward cycles to keep children engaged and immersed for the delivery of therapeutic activity.
“This innovative study represents, to my knowledge, the largest and most rigorous evaluation of a digital medicine,” stated Scott Kollins, PhD, Professor of Psychiatry, Director of the ADHD Program at the Duke University School of Medicine. “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. 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.”
AKL-T01 was safe and well-tolerated with 11 treatment-related adverse events reported, primarily headache and frustration. No serious adverse events were observed, and one patient discontinued treatment. The treatment and active control group showed statistically significant improvement from baseline on a range of subjective behavioral secondary outcome measures.
Akili plans to file AKL-T01 with the US Food and Drug Administration (FDA) for clearance as a novel treatment for children and adolescents with ADHD.
Akili achieves primary efficacy endpoint in pediatric ADHD pivotal trial. Akili. December 4, 2017. Available at: https://www.akiliinteractive.com/news-collection/akili-achieves-primary-efficacy-endpoint-in-pediatric-adhd-pivotal-trial