New Data Supports Use of Digital Treatment for ADHD

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Akili announced new data on its therapeutic EndeavorRx, an FDA-cleared digital treatment for children diagnosed with attention-deficit/hyperactivity disorder (ADHD). The data, which highlights real-world improvements and benefits, includes results from the STARS-Adjunct trial, a multi-site open-label study created to examine the impact of EndeavorRx on impairments in daily life scenarios for children with ADHD. The initial presentation of data occurred this week at the American Academy of Child and Adolescent Psychiatry (AACAP) 2020 Virtual Annual Meeting.

“The STARS-Adjunct study provides further evidence for physicians on the use of EndeavorRx in clinical practice, including duration of treatment and use alongside traditional ADHD medications,” said Anil Jina, MD, chief medical officer of Akili, to press. “Building on the improvements in objective measures of attention demonstrated in our prior clinical studies of EndeavorRx, these data help show the benefits of treatment seen by parents assessing their child’s ADHD-related impairments in everyday life.”¹

The study included 206 pediatric participants aged 8-14 years with a diagnosis of ADHD, across 2 cohorts: children who were taking ADHD stimulant medications and children who were not taking ADHD medications for the duration of the study. Children completed 1 month of treatment with EndeavorRx, followed by a 1 month pause and then another 1-month treatment with EndeavoRx.

Administered as a video game experience, EndeavorRx is shown to improve attention function as ascertained by computer-based testing in children aged 8-12 with primarily inattentive or combined-type ADHD. It is not intended to be used as a sole treatment and is not an adequate replacement for a child’s medication.

Several key results about EndeavorRx were revealed in the presentations. First, both children taking stimulants and those not taking any ADHD medication demonstrated similar and statistically significant improvements on the ADHD Impairment Rating Scale (IRS) compared to baseline.

Second, observations from parents showed half of children responded to the treatment following 1 month of usage. Improvements remained stable for 1 month following treatment.

Third, 34.5% of children no longer showed attention impairment on at least 1 aspect of objective attention post-treatment.

Lastly, early evidence suggests children who improved in attention functioning following treatment also improved their math and reading skills, as demonstrated by their performance on the Test of Silent Reading Efficiency and Comprehension (TOSREC) and the Mathematics Fluency and Calculation Tests (MFaCTS).

Reference

1. Researchers Present New Outcome Data for Akili Digital Therapeutic EndeavorRx™ in Pediatric ADHD. News release. Business Wire. October 21, 2020. https://www.businesswire.com/news/home/20201021005068/en/Researchers-Present-New-Outcome-Data-for-Akili-Digital-Therapeutic-EndeavorRx™-in-Pediatric-A DHD​