Akili Interactive Labs, Inc., a company focused on developing clinically validated digital medicine for cognitive assessment and personalized treatment, announced today data from the Akili-001 pediatric attention deficit hyperactivity disorder (ADHD) pilot study of Project: EVO, its lead therapeutic product candidate. The study confirmed Project: EVO's safety and feasibility. Additionally, exploratory outcome measurements demonstrated that Project: EVO improved attention, inhibition and working memory in children with ADHD. These data were presented at the American Academy of Child and Adolescent Psychiatry's 62nd annual meeting.
"These data demonstrate that Project: EVO improved attentional functioning and working memory in children with ADHD," said Scott Kollins, PhD, lead author and principal investigator for the study, and Professor of Psychiatry and Director of the ADHD Program, Duke University School of Medicine. "While results are preliminary, these data provide a strong rationale for continued work to develop this novel, digital intervention for ADHD."
In the Akili-001 open-label pilot study, Project: EVO was tested in a total of 80 children between the ages of 8 and 12 years, 40 of whom were diagnosed with ADHD and not taking a medication, and 40 of whom had no psychiatric diagnosis. The regimen consisted of using the digital intervention delivered through an action video game interface on a tablet device at home for approximately 30 minutes per day, five times a week over the span of four weeks. The primary aims of the study were to confirm feasibility and safety of the at-home intervention, as well as to measure the difference in baseline attentional functioning between the two groups. Exploratory measures of attention, impulsivity, and working memory were also assessed at one month. Improvement was seen across these domains in the ADHD group.
Statistically-significant improvements were observed in the ADHD group on multiple outcome measures, including the Attention Performance Index (API) of the Test of Variable of Attention (T.O.V.A.®), a continuous performance test used to measure attentional function; in the ADHD group (p = 0.033, Cohen's d = 0.35, n=40); there was no statistically significant change in the non-ADHD group (p = 0.30, Cohen's d = 0.16, n=40). Other statistically significant improvements for the ADHD group were observed in impulsivity and variability measurements on T.O.V.A., and in multiple measurements on the CANTAB (Cambridge Cognition) spatial working memory test.
Additionally, a post-hoc analysis of participants' API scores showed that the intervention had a significantly larger attention effect on a subgroup of the children with ADHD who exhibited more substantial attention impairment at the beginning of the study (p = 0.003, Cohen's d = 0.71, n=22). This sub-group displayed similar improvements to the full ADHD group on the working memory tests, on impulsivity measures and a parent-reported scale of executive function.
There was an 81 percent compliance rate for use of the digital intervention among those tested (on average, 9.1 hours of playtime over 4 weeks). A large majority of the parents of the ADHD participants indicated in reports that the game was worthwhile for their child. A total of nine adverse events were reported during the study, but none were deemed related to the Project: EVO intervention. Importantly, there were no dropouts within the ADHD group.
"Project: EVO was designed as medical-grade software that could potentially offer a viable new option or adjunct to pharmaceuticals," said Eddie Martucci, co-founder and CEO of Akili. "This study supports that hypothesis, and we are excited to continue to explore Project: EVO's utility in pediatric ADHD in larger confirmatory studies." Akili's product candidate, Project: EVO, is based on a platform technology exclusively licensed from the lab of Dr. Adam Gazzaley at the University of California, San Francisco and was previously published as the cover story of Nature, where a prototype of the technology showed large improvements in attention and working memory in healthy older adults after at-home intervention. The mechanics are designed to directly target an individual's ability to process "cognitive interference" - specifically, the ability to deal with multiple streams of sensory information, which has the potential to improve higher-order executive functions such as problem solving, working memory, and self-regulation. The Project: EVO platform targets cognitive interference processing while also adapting difficulty automatically in real-time, allowing individuals of wide-ranging ability levels to interact with the product without the need for physician calibration.
Based on these promising data, Akili plans to initiate a large, randomized, controlled pivotal study in the coming months to further validate the efficacy and safety of Project: EVO as a treatment for pediatric ADHD. Akili is currently conducting multiple clinical studies of the technology platform across a variety of patient populations, including pediatric Autism Spectrum Disorder (in strategic collaboration with Autism Speaks), depression, Alzheimer's disease (in strategic collaboration with Pfizer, Inc.) and traumatic brain injury.