Akili Interactive Labs, an affiliate of Boston-based PureTech Health, has reported that its late-stage study of a video game designed to treat adolescents with ADHD has reached its primary endpoint.
Its lead investigational digital medicine, AKL-T01, showed a statistically significant improvement compared to an active control on the predefined primary endpoint, a change in the Attention Performance Index (API), a composite score from the Test of Variables of Attention (T.O.V.A.).
The T.O.V.A. is an objective measure of sustained attention and inhibitory control. AKL-T01 was shown to be safe in this study, with no serious adverse events observed.
Based on the results, Akili said it is planning to file AKL-T01 with the US FDA for clearance as a novel treatment for children and adolescents with ADHD.
“This innovative study represents, to my knowledge, the largest and most rigorous evaluation of a digital medicine,” said Scott Kollins, Professor of Psychiatry, Director of the ADHD Program at Duke University School of Medicine and principal investigator for the study.
“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 driven by the therapeutically active component in AKL-T01 and not just the video game experience.”