A Single Arm Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adolescents Diagnosed with Attention Deficit Hyperactive Disorder (ADHD)

Abstract: STARS-ADHD-Adolescents was a multicenter, single-arm trial conducted at 14 US research sites to evaluate objective attention functioning and ADHD symptoms and impairments after 4 weeks of AKL-T01 treatment in adolescents aged 13-17 years. Enrolled patients had a confirmed diagnosis of ADHD (combined or inattentive) and attentional impairment with Test of Variables of Attention (TOVA) Attention Comparison Score (ACS) of -1.8 or below. Participants were asked to complete AKL-T01 treatment at home in combination with their previously established stable regimen, which could include medication and/or nonpharmacological therapies. The primary endpoint was 4-week change in the TOVA-ACS. Secondary endpoints of this study were 4-week change in the ADHD RS-5 inattention scale and total scale scores. Of the 526 participants who were screened for this study, 162 participants were enrolled between July 29, 2021 and September 1, 2022, and 146 had sufficient data for inclusion in the Efficacy Population. The mean age was 14.3 years, and the majority were male (59%), White (77%), and not Hispanic or Latino ethnicity (82%), with 49% reporting current stimulant use. AKL-T01 met its primary efficacy endpoint with a significant positive mean change after 4 weeks in the TOVA-ACS of 2.6 (95% CI: 2.02, 3.26; P