After reporting positive results of a lead investigational digital medicine, a company is planning to file for FDA approval of a video game to treat attention-deficit/hyperactivity disorder.
Could physicians prescribe digital medicine in the form of a video game for children and teenagers with attention-deficit/hyperactivity disorder (ADHD)? That’s what Akili Interactive, an affiliate of PureTech Health, is hoping after reporting positive results of its lead investigational digital medicine, AKL-T01.
The company said it is planning to file AKL-T01 with the FDA for approval after results of a randomized, controlled trial of 348 children and adolescents with ADHD showed a statistically significant improvement compared with an active control (P = .006). The predefined primary endpoint looked for a change in the Attention Performance Index (API), a composite score from the Test of Variables of Attention, an objective measure of sustained attention and inhibitory control.
“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,” Scott Kollins, PhD, professor of psychiatry, director of the ADHD Program at Duke University School of Medicine, and principal investigator for the study, said in a statement.
Current clinical guidelines for ADHD call for a combination of prescription medications and cognitive behavioral therapy.
AKL-T01 was found to be safe, with no serious adverse events. Subjective secondary outcome measures showed statistically significant positive improvements in both the treatment and active control groups, though there was not a statistically significant separation on those measures between groups.
“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,” Kollins said.
The company said full results will be presented at an upcoming scientific conference and submitted for publication in a peer-reviewed journal.