CONTEXT: This peer reviewed report on an open label extension to a pivotal ADHD study wouldn’t normally get out attention, but the treatment of kids using digital tech had us hooked | This is way more than game tech and carries the FDA approval | So good to see non-pharmacological solutions being successfully explored in this field.
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1. “BOSTON–(BUSINESS WIRE)–Akili Interactive (“Akili” or “Company”), today announced the publication of full data from a multi-site open-label study (STARS Adjunct) evaluating the impact of EndeavorRxTM (AKL-T01) on symptoms and functional impairments in children with attention- deficit/hyperactivity disorder (ADHD).”
2. “Statistically significant improvement was demonstrated in all predetermined endpoints of the study, which included parent and clinician ratings of children’s ADHD symptoms and related impairments in daily life.”
3. “A change in the ADHD Impairment Rating Scale (IRS), a parent-reported assessment scale of ADHD- specific impairments observed in their child’s day-to-day life, was the primary outcome measure of the study.”
4. ““The findings from this latest study offer additional information about the effectiveness of EndeavorRx in children treated with front-line pharmacotherapy for ADHD,” said Scott Kollins, Ph.D., Professor of Psychiatry and Director of the ADHD Program at the Duke University School of Medicine, faculty member at the Duke Clinical Research Institute (DCRI), and lead author of the publication.”
5. “Based on the totality of data from those studies which showed clinical benefit in attention as measured by computer-based testing, academic performance measures, and other assessment tools, EndeavorRx was cleared by the U.S. Food and Drug Administration (FDA), making it the first prescription treatment delivered through a video game.”