“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 significant 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 … 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.”
“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,” said Eddie Martucci, CEO of Akili. “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.”
More than 5.5 million children diagnosed with ADHD struggle with attention issues. Inattention and other “silent” cognitive issues often go unrecognized in the face of other more overt disease symptoms, yet they significantly impact daily functioning. “Children with ADHD are joined by millions of others, both with and without medical diagnoses, who experience challenges in their daily lives due to inattention or other cognitive issues. We’re committed to driving greater awareness and recognition of the impact of these cognitive issues and advancing novel approaches to help all those affected,” said Anil Jina, M.D., Akili’s Chief Medical Officer.
News in Context:
- Study: Having ADHD costs $1.1 million in lower lifetime earnings, even when “treated”
- Reinventing Brain Medicine, Pharma adopts Digital Therapeutics: Evidence-based videogames, smartphone apps, and sensors
- Pending FDA review and approval, research findings pave way for Akili’s EVO to become first brain training platform prescribed for ADHD
- The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation