Boston-based Akili Interactive Labs has announced positive results from the largest clinical trial of its video game-based pediatric ADHD treatment yet. In light of these data, the company announced that it now plans to file AKL-T01, also known as Project: Evo ADHD Treatment, for FDA clearance as a novel treatment for children and adolescents with ADHD

“This is, any way you slice it, our largest, most rigorous trial on the path to registration and bringing this to patients, so we’re very excited about it,” Akili President and CEO Eddie Martucci told MobiHealthNews. “In the past … we’ve had various smaller scale trials that have looked at children with ADHD and related psychiatric issues. This trial was designed to be the highest bar we could think of on our path to true medicine validation.”

Based on research from UCSF, AKL-T01 is a video game specifically designed to treat cognitive conditions. To play it, a user navigates an alien avatar down a course by tilting a mobile device back and forth. While navigating the alien, the user must also respond to targets by tapping the screen. The app keeps track of movements and can therefore monitor the user’s behavior and quickly adapt to the player.

“The technology at its core is a set of algorithms that can render sensory stimulus in very specific ways,” Martucci said. “The delivery mechanism, almost like the analogy of the capsule, is the video game … we’re stimulating very specific neural circuitry, but the patient feels like they are experiencing a video game.”

The multi-center, randomized, double-blind, active-controlled STARS-ADHD study was announced last year but began piloting in November 2015. In it, researchers enrolled 348 children with ADHD and aged 8 to 12 years across 20 study sites and gave them an iPad with either the AKL-T01 intervention or another game that was non-therapeutic. All participants received a recommendation to play their game for 30 minutes five times a week. After the four-week study period, researchers compared the participants’ Attention Performance Index (API) scores — a composite score from the FDA-condoned Test of Variables of Attention (TOVA) — with those recorded just prior to the study period.

According to Akili, participants who received AKL-T01 demonstrated a significant improvement in API scores over those who were enrolled in the active control group. The therapy was generally well-tolerated, with 11 treatment-related adverse events such as headache and frustration reported. Both study groups showed significant improvement in a number of subjective behavioral measures that served as the study’s secondary outcomes, but none of these were significantly different between the two groups.

“This innovative study represents, to my knowledge, the largest and most rigorous evaluation of a digital medicine,” Dr. Scott Kollins, professor of psychiatry, and director of the ADHD Program at Duke University School of Medicine, and principal investigator for the study, said in a statement. “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.”

Martucci said that Akili has been speaking with the FDA on what data would be needed to clear AKL-T01 for pediatric ADHD, and designed the study with the agency’s considerations in mind. As such, Martucci said that they are beginning to pursue the clearance, and will release a more detailed analysis of the study’s results in the coming year.

“We’re obviously excited that we hit the primary endpoint with high statistical significance,” he said. “We were really pleased with the fact that we had no serious adverse effects and only a single child dropped out from the 180 children that were on our treatment product.”

While AKL-T01 stands as Akili’s most prominent offering, the company produces a number of digital therapies for cognitive deficiency and symptoms of neurologic and psychiatric conditions. In April, a University of California, San Francisco study published in PLOS One suggested that the company’s technology could also be beneficial for children with Sensory Processing Disorder. Another, from 2016, also provided evidence that the platform could also detect biomarkers of Alzheimer’s disease.