A Single-Arm Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention for Attention, in Adults Diagnosed with Attention Deficit Hyperactivity Disorder

Objectives Rates of attention deficit hyperactivity disorder (ADHD) have increased among adults, and barriers to treatment (e.g., medication shortages; inaccessibility of behavioral treatments) underscore need for novel, scalable interventions. There is a particular need for treatments for inattentive symptoms, which are the most frequently endorsed ADHD symptoms in adults. AKL-T01 (EndeavorRx®) is an FDA-authorized digital therapeutic, currently approved for attention in children ages 8-12 with inattentive or combined-type ADHD and a demonstrated attention issue. This study evaluated the efficacy and safety of AKL-T01 in adults. Methods STARS-ADHD-Adults (NCT05183919) was a multicenter, single-arm trial at 14 US sites. Enrolled patients were 18 or older, had a diagnosis of ADHD (combined or inattentive), and demonstrated attentional impairment with a Test of Variables of Attention (TOVA) Attention Comparison Score (ACS) ≤ -1.8. Treatment involved using AKL-T01 at home 25 minutes/day, 5 days/week, for 6 weeks. The primary endpoint was change in TOVA-ACS. Secondary endpoints were changes in the ADHD Rating Scale-IV (ADHD-RS-IV) inattention subscale and total score, and Adult ADHD Quality of Life (AAQoL) total score. Safety, tolerability, and compliance were assessed. Results Of 440 participants screened, 221 were enrolled, and 153 ( M age = 39.9, 70% female; 39% current stimulant use) had sufficient data for analysis. TOVA-ACS significantly improved from baseline to study day 42, M change = 6.46, SD = 6.95, t (152) = 11.49, p <.0001. There was significant improvement across all secondary endpoints ( p s <.0001). In exploratory responder analyses, 36.6% moved into the normative range on TOVA (ACS>0), and 27.1% had ADHD-RS-IV improvement ≥ 30%. The treatment was well-tolerated (5% reported ADEs; none serious), and compliance was high ( M = 81.1%). Conclusions Results support the efficacy of AKL-T01 in adults, and the magnitude of TOVA change in adults was nearly 7x the change reported in pediatric trials. Given the increasing rates of ADHD in adults, the barriers to accessing evidence-based treatments, and the centrality of inattentive symptoms as ADHD patients develop into adulthood, AKL-T01 holds promise as a scalable, targeted treatment for attention in adult ADHD with impacts to real-world symptoms. Funding Akili Interactive