Akili Interactive Labs announced the publication of full data from a single arm, unblinded study conducted by Dr. Elysa Marco at Cortica Healthcare and Drs. Joaquin Anguera and Courtney Gallen at the University of California, San Francisco. The study measured electroencephalography (EEG) data alongside behavioral and clinical metrics of attention in children with ADHD using AKL-T01 (EndeavorRx). Data from the study show that EndeavorRx treatment resulted in increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention. The study results were published in the medical journal PLOS ONE.
How did the study work?
In this study, attention in children with ADHD was evaluated using a well-established EEG-based measure of attentional control, midline frontal theta (MFT) activity. Data show that EndeavorRx enhanced MFT activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function. Study results also demonstrated a correlation between MFT activity and attention functioning, suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention. Additionally, parents reported significantly fewer inattention symptoms in children treated with EndeavorRx, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
This was a single arm, unblinded study of 25 children, 8-12 years old, with a confirmed diagnosis of ADHD. Study participants were instructed to use EndeavorRx for approximately 25 minutes a day at least 5 days a week for 4 weeks. Assessments to detect intervention-related changes were performed before (Day 0) and after (Day 28) EndeavorRx treatment and included stimulus-locked EEG to detect changes in neural signals, two computerized tasks to index objective improvements in attentional control, and a subjective questionnaire asking parents about their children’s ADHD symptoms.
EndeavorRx is the first-and-only FDA-cleared treatment delivered through a video game experience. In the U.S., EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. The most common side effect observed in children in EndeavorRx’s clinical trial was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. The U.S. commercial launch of EndeavorRx is planned for the second half of 2022.
On the record
“While the previous multicenter trials have demonstrated attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD. It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Elysa Marco, M.D., Principal Investigator of the study, and Clinical Executive for Neurodevelopmental Medicine at Cortica Healthcare.
“EndeavorRx was designed to target and activate attention networks in the brain with the aim of driving clinically meaningful cognitive changes in patients,” said Anil S. Jina M.D., Chief Medical Officer of Akili. “What’s especially exciting about this data is that, for the first time, we can see how the neural systems of a child with ADHD are impacted with EndeavorRx treatment. We look forward to continuing to learn about how the digital therapeutic can help children with ADHD in their daily lives.”
The context
EndeavorRx has been rigorously evaluated across five clinical studies in more than 600 children diagnosed with ADHD, including STARS-ADHD, a prospective, randomized, controlled study published in The Lancet Digital Health. This is the first study to use EEG data to illustrate how EndeavorRx impacts activity in the brain for children with ADHD. In addition to FDA clearance, the digital therapeutic has received Conformité Européenne (CE) Mark certification in Europe for use in pediatric ADHD. The disease-agnostic proprietary technology underlying EndeavorRx is also being studied by Akili in multiple other medical conditions with associated chronic and acute cognitive impairments, including autism spectrum disorder, multiple sclerosis, major depressive disorder, COVID-19 brain fog, cancer-related cognitive impairment and postoperative cognitive dysfunction.