Editor's note: The original version of this story claimed that STARS-ADHD Adjunctive enrolled 2016 subjects, instead of 206. We apologize for this error.
Digital therapeutic company Akili Interactive has announced the first results of an open-label, multisite pediatric ADHD trial providing some patients with the company’s video game-like treatment alongside a stimulant medication.
According to the company, both those who received the AKL-T01 therapy with (n = 130) or without (n = 76) accompanying stimulant medication saw significants improvements one month after baseline (p < .001) as measured by the trial’s primary outcome, ratings on the ADHD Impairment Rating Scale (IRS) reported by parents.
Following this treatment period, patients took a one-month break from the digital therapeutic, during which those in the stimulant group continued to receive their other medication. AKL-T01 was again provided during the study’s third month, during which the company said parents and clinicians alike observed “additional improvements.” Researchers did not observe any serious adverse events among patients over the course of the study.
While a full reporting of the study data is still being prepared for upcoming conferences or journal publication, Akili views these findings as evidence that AKL-T01 provides a benefit “independent of whether the children were on or off ADHD medication.”
HOW IT WAS DONE
In the Duke Clinical Research Institute-managed study, researchers enrolled 206 children aged eight to 14 years with a diagnosis of ADHD. Those in the stimulant group were required to have been adherent to a stimulant medication — but inadequately managed by that stimulant — for at least 30 days before baseline.
Although the primary outcome looked at IRS scores after one month of treatment, the children’s caretakers monitored daily symptoms over the full three-month study period using an app provided by Akili. Other secondary outcome measures included the ADHD Rating Scale, Tests of Variables of Attention and the Clinical Global Impression - Improvement Scale.
THE LARGER TREND
Akili described the STARS-ADHD Adjunctive trial as a follow-up to the pivotal trial of its AKL-T01 therapy, the STARS-ADHD trial. This study enrolled 348 children with ADHD to receive either the digital therapeutic or another non-therapeutic game over the course of a four-week study period.
Positive results from this trial were the cornerstone of Akili’s pending FDA regulatory clearance. Submitted in early 2018, the company is still awaiting the agency’s final decision.
In the meantime, the company has been continuing development on other experimental therapies in its pipeline, such as another video game-like treatment for adults living with major depressive disorder.
ON THE RECORD
“Following our successful pivotal STARS-ADHD study of AKL-T01 as a potential treatment for inattention in children with ADHD not taking stimulant medications, understanding the benefit of our technology when used alongside ADHD medications has been a research priority for us. Importantly, parents see improvements in their children regardless of whether they are using the treatment alone or alongside stimulants,” Eddie Martucci, CEO of Akili, said in a statement. “As we continue to work toward FDA clearance for this novel therapeutic for inattention in children with ADHD, these data and the benefits expressed by parents and physicians in this study lend further credence to the important role AKL-T01 can play in the treatment of ADHD.”