The Akili Interactive Labs’ digital therapeutic EndeavorRx™ improved attention in two-thirds of children diagnosed with attention-deficit/hyperactivity disorder (ADHD) who used the software for two months. Data across four clinical trials consistently demonstrate over one-third of children with ADHD no longer showed attention impairment on at least one measure of objective attention. Improvements in attention during treatment were associated with improvements in math and reading performance. EndeavorRx can be used alone or with stimulants.

The outcomes are from the STARS-Adjunct trial, a multi-site open-label study designed to evaluate the impact of EndeavorRx™ on impairments in daily life in children with ADHD. Key results are as folllows:

• Improvements in the ADHD Impairment Rating Scale (IRS) were statistically significant compared to baseline and were similar in magnitude regardless of whether or not children were taking stimulant medication:
• Parent observations showed half of children responded to treatment following one month of EndeavorRx use and improvements remained stable for one month following treatment.
• Improvements increased with longer duration of treatment, with more than two-thirds of children responding to treatment following two months of EndeavorRx use.
• Over one-third of children no longer showed attention impairment on at least one measure of objective attention following treatment.
• Early exploratory evidence showed children who improved in attention functioning following treatment also improved their math and reading skills. Their performance on the Test of Silent Reading Efficiency and Comprehension (TOSREC) and the Mathematics Fluency and Calculation Tests (MFaCTS) improved in children whose Test of Variables of Attention (TOVA) Attention Comparison Score (ACS/API) improved.

EndeavorRx is an FDA-cleared digital treatment for children diagnosed with ADHD. Delivered through a video game experience, EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. EndeavorRx is built on the Akili Selective Stimulus Management Engine (SSME™) core technology, a proprietary technology designed to target key attentional control systems in the brain. SSME presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalize the treatment experience for each individual patient.

The STARS-ADHD Adjunct study (NCT03649074) was a three-month open-label, multi-site study with 130 children taking ADHD stimulant medications and 76 not taking medications for the duration of the study. Each child completed one month of treatment with the software, a one-month pause, and then another month of treatment. The primary outcome measure was the change from baseline after one month in the Impairment Rating Scale (IRS) for each cohort. Secondary outcome measures included the ADHD Rating Scale (ADHD-RS), Test of Variables of Attention (TOVA), Clinical Global Impression – Improvement Scale (CGI-I), as well as exploratory outcomes of academic performance measures (TOSREC, MFaCTS).

This was reported by Akili Interactive Labs on October 21, 2020.

Contact information: Julie DiCarlo, Senior Vice President, Communications, Akili Interactive, 125 Broad Street, 5th Floor, Boston, Massachusetts 02110; 617-306-5823; Email: julie@akiliinteractive.com; Website: https://www.akiliinteractive.com/