Exploring Minimum Effective Usage Time for a Digital Neurotherapeutic

Poster Session F - Tuesday, April 16, 2024, 8:00 – 10:00 am EDT, Sheraton Hall ABC

Tony J. Simon¹ (tsimon@akiliinteractive.com), Heather M. Shapiro^1,2, Andrew C Heusser¹; ¹Akili Interactive, Inc, ²Berkana Data

Digital therapeutics (DTx) are software-based treatments that deliver evidence-based interventions via devices like mobile phones and XR headsets. The technology underlying Akili’s AKL-T01 treatment for ADHD has been evaluated in a pediatric randomized controlled trial and open-label trials across pediatric and adult populations. The treatment protocol for these trials was 25 minutes of engagement per day, 5 days per week. While common for cognitive DTx, and informed by animal studies, this “dosage” level has yet to be examined for efficacy in real-world settings. We analyzed de-identified data from 145 adults in a clinical trial of AKL-T01 and from 2330 adult commercial users of EndeavorOTCⓇ (AKL-T01). We sought to determine whether using the 25-minute regimen with AKL-T01 is necessary to generate the cognitive and clinical improvements reported from the adult trial. The trial data showed that the equivalent of 10-15 minutes daily AKL-T01 engagement for six weeks was sufficient to produce meaningful clinical outcomes. These were a median 4.8 point improvement on the Attention Composite Score (ACS) on the Test of Variables of Attention (TOVAⓇ) and a median 22.3 point gain in Akili’s Focus ScoreTM measurement, a clinically-validated proprietary composite measure of key attentional functions. Importantly, the same level of AKL-T01 engagement that was effective for trial participants (10-15 minutes daily) was sufficient to generate comparable Focus Score improvements in commercial users. Our findings suggest that clinical benefit can be generated with a reduced treatment time burden, which may also enhance user retention.

Topic Area: OTHER