Project: EVO™


Study Director: Elysa Marco, Joaquin Anguera, Adam Gazzaley

Sponsor: Wallace Research Foundation 

Recruiting?: No

Official study title: ProjectEVO

Conditions studied: Sensory Processing Dysfunction, Autism, ADHD

Purpose: This SPD and inattention study using EVO and funded by the Wallace Research Foundation has set the stage for a multi-center, randomized, double-blind, active-controlled pivotal study of AKL-T01 in pediatric ADHD. This is the first study of its kind, evaluating a potential new digital medicine as you would a drug to treat disease. If cleared by FDA, physicians will be able to prescribe AKL-T01 to treat ADHD patients just as they currently prescribe pharmaceuticals. 


Akili just announced the results of their pivotal trial in pediatric ADHD, showing a positive primary endpoint and encouraging additional effects across various patients. It's time to put the pedal to the metal and bring this to patients!  

"In the randomized, controlled trial of 348 children and adolescents diagnosed with ADHD, AKL-T01 showed a statistically significant improvement compared to an active control (p=0.006) 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. 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 between the groups. Full analysis of pre-specified secondary and exploratory outcomes and subgroup responses is underway and we look forward to presenting the results of the study at an upcoming scientific conference and submitting for publication in a peer-reviewed journal." 

You can read the full release here.