Akili with its partner Shionogi announced the beginning of a pivotal Phase III trial, designed to evaluate the safety of the product candidate for children ages 6-17 with ADHD, and to improve measures of their attention. Caregivers and health care providers are looking for non-drug treatment options which is why the trial is an important step towards the goal to help all eligible children with ADHD worldwide. The study is being conducted across multiple sites in Japan which is expected to enroll approximately 150 children ages 6-17 years diagnosed with ADHD. Participants who receive the treatment use the video game-based cognitive intervention and then their attention function is assessed by physicians using the ADHD-RS-IV inattentive subscale. The digital technology from Akili is designed to treat impaired cognitive function, specifically attention designed to target and activate the neutral systems while using adaptive algorithms to personalize the treatment experience.
Read more about this news release here.