The first-of-its-kind prescription digital medicine video game plans for regulatory filing in the first half of 2018.
Eddie Martucci, PhD
Boston-based Akili Interactive has announced top-line results from the STARS-ADHD pivotal study of its investigational digital therapeutic medicine AKL-T01, in treatment of pediatric attention-deficit/hyperactivity disorder (ADHD).
AKL-T01, the company’s ADHD treatment in development, is a first-of-its-kind prescription digital medicine being evaluated as a potential treatment for pediatrics with ADHD.
“Children affected by ADHD can experience fundamental challenges with attention and impulse control, which can lead to serious limitations in daily life," Eddie Martucci, PhD, president and chief executive officer, Akili, told MD Magazine. "Our technology is directed at these attentional impairments through specific sensory stimuli that targets neurological function, and this study was the first very important step to rigorously evaluate AKL-T01 as a potential new digital treatment for pediatric ADHD through this direct targeting approach. We're very happy to see that children with ADHD treated with AKL-T01 showed a significant positive improvement in attention compared to an active control game, and we look forward to further data analysis and additional research to understand AKL-T01’s full potential."
The digital medicine, AKL-T01, is a video game for patients to play on tablet devices. It uses the same storytelling and reward mechanisms as standard videogames; however, it features mechanisms to act on neural systems and algorithms that dial the level of stimulus up or down, meeting the needs of the patient.
In the STARS-ADHD randomized, controlled trial of 348 children and adolescents diagnosed with ADHD, AKL-T01 showed a statically significant improvement compared to an active control group on the predefined primary endpoint, a change in the Attention Performance Index (API), a composite score from the Test of Variables of Attention (TOVA).
Secondary outcome measures showed statistically significant positive improvements in both the treatment and active control arms, although there was not a significant separation on the measures between both groups.
The trial evaluated patients with ADHD and objective attention deficits before and after 4 weeks of at-home treatment with either AKL-T01 or an active control that was designed and tested to have a similar level of expectation of benefits and engagement.
Researchers recommended that children complete a 30-minute session of the game 5 days a week.
The active control application was deployed in the same format as AKL-T01, a mobile tablet, and mimicked the reward and engagement however deployed different stimuli than the therapeutically-active component.
After the 4-week period, an assessment measured changes from baseline on standard measures of attention, memory and impulsivity.
Children and adolescents that received AKL-T01 showed a statistically meaningful improvement in attentional functioning on the API.
Secondary outcomes included subjective parent-reported behavioral ratings.
AKL-T01 was well tolerated and safe, with only 11 treatment-related adverse effects: primarily headache and frustration. No serious adverse effects were reported, and only 1 patient discontinued treatment.
Engineered as a therapeutic active treatment for cognitive deficiency, AKL-T01 is built on Akili’s patented Project: EVO technology platform that allows selective targeting and activation of specific cognitive neural systems in the brain that exhibit deficiency from various medical conditions.
The technology uses adaptive algorithms to deliver the presentation of stimuli that engage targeted neural in the prefrontal cortex. In a closed-loop system, the algorithms automatically adjust the level, or dose, for a personalized treatment experience tailored to the needs of individual patients.
The treatment looks and simulates a high-end video game with art, music, storytelling and reward cycles to engage patients in the delivery of therapeutic activity.
“This innovative study represents, to my knowledge, the largest and most rigorous evaluation of a digital medicine,” Dr. Scott Kollins, principal investigator of the study, professor of psychiatry, director of the ADHD program, Duke University School of Medicine, 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 drive by the therapeutically active component in AKL-T01 and not just the video game experience.”
Akili plans to file for regulatory approval with the US Food and Drug Administration in the first half of 2018 for clearance as a novel treatment for children and adolescents with ADHD, paving the way for the first ‘digital’ prescription product to directly treat a disorder.
The company is also studying whether a similar version of its video game could potentially treat adults with depression, and the Akili recently started a mid-stage clinical trial with early results expected late next year.
A press release has been made available.