Early Data on a Potential Digital Treatment for Autism+ADHD
Digital medicine company Akili Interactive announced the results of a successful randomized, controlled clinical trial of an investigational digital treatment for children with Attention Deficient/Hyperactivity Disorder (ADHD). This digital medicine improves a key component of cognition that is thought to contribute to attention difficulties in children with ADHD. But, instead of being administered through a pill, the treatment is delivered through a video game-like environment. Akili is now pursuing FDA clearance for the innovative treatment so that doctors can prescribe it to patients just as they would a drug. This is exciting news in both the ADHD world and the world of digital medicine, as the treatment would become the first ever prescription digital medicine to treat ADHD symptoms in children. In a statement announcing the clinical trial’s success, Akili’s co-founder and CEO, Eddie Martucci, Ph.D. said, “This is an exciting milestone for our company, for the digital therapeutic community, and for families and children affected by ADHD. We look forward to advancing AKL-T01 through our planned regulatory process and toward the market.”
Building off their success, and in partnership with the Center for Autism Research (CAR), Akili has conducted a pilot study, with promising results, to evaluate the feasibility and initial efficacy of the treatment, called Project: EVO, in children with autism spectrum disorder and co-occurring ADHD. Research estimates as many as 30% or more of children with autism also have ADHD, and a lower percentage of children diagnosed with autism and ADHD diagnoses respond to traditional ADHD treatments. Led by Benjamin Yerys, a scientist at CAR, the initial pilot study found that not only did the child participants like and engage with the treatment, their attention on a classic test of attention improved similar to what was seen in children with ADHD alone. However, children receiving the control treatment -- an alternative digital treatment with an educational focus -- did not improve on the test of attention. Parents also reported significant changes in attention for children receiving Project: EVO, and these changes were roughly twice as much as what was reported by parents of children receiving the educational treatment. “This treatment is attempting to improve attention by helping a child’s brain ignore distractions and stay focused on the task at hand. The long-term goal is that developing these skills will generalize to life outside of the treatment,” explains Dr. Yerys.
Plans are now underway now for a larger clinical trial. Dr. Yerys shares his thoughts for the upcoming study, “I’m eager to begin the next phase of research with Project: EVO. We know that children with co-occurring autism and ADHD are having more difficulty with functioning in everyday life, and don’t respond as well to ADHD treatments as children with ADHD and no autism. So testing new treatments that can be deployed to many families quickly if successful, is a priority for me.”
For more information on CAR’s initial pilot study using Project: EVO, visit our blog, Driven.