BOSTON--(BUSINESS WIRE)--Akili today announced multiple data presentations on EndeavorRxTM (see prescribing information below), including results 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 attention-deficit/hyperactivity disorder (ADHD) and inform prescribing practices. Also presented were analyses across four clinical trials of EndeavorRx, evaluating the impact of treatment on children’s attention function compared to normative ranges. The data were presented for the first time 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, M.D., Chief Medical Officer of Akili. “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.”
Key results across the presentations include:
- 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 medication1: Both children taking stimulants and those not taking any ADHD medication demonstrated similar and statistically significant improvements (children on stimulants: mean improvement −0.7, p < 0.001; and children off stimulants: mean improvement −0.5, p < 0.001).
- Parent observations showed half of children responded to treatment following one month of EndeavorRx use and improvements remained stable for one month following treatment2: Half of parents reported improvements in their child’s ADHD-related impairments in daily life following one month of EndeavorRx treatment as measured by the IRS (responders/improvement of one point or more on the IRS scale: 50.0%).
- Improvements increased with longer duration of treatment, with more than two-thirds of children responding to treatment following two months of EndeavorRx use2: More than two-thirds of parents reported improvements in their child’s ADHD-related impairments following a second month of treatment as measured by the IRS (responders/improvement of one point or more the IRS scale: 68.3%).
- Over one-third of children no longer showed attention impairment on at least one measure of objective attention following treatment3: Analyses across four studies in pediatric ADHD4 showed that overall 34.5% of children moved into the normative range on at least one TOVA objective measure of attention following four weeks of EndeavorRx treatment (N=296 children aged 8 to 15 years old with ADHD and TOVA impairment at baseline).
- Early exploratory evidence showed children who improved in attention functioning following treatment also improved their math and reading skills4: 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 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally-assessed measure Test of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs; which further address symptoms of the disorder. EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication.
About the STARS-ADHD Adjunct Study
The STARS-ADHD Adjunct study (NCT03649074) was a three-month open-label, multi-site study of AKL-T01 (EndeavorRx) in 206 pediatric participants aged 8-14 years with a diagnosis of ADHD, across two cohorts: children who were taking ADHD stimulant medications (n=130) and children who were not taking ADHD medications (n=76) for the duration of the study. Children completed one month of treatment with AKL-T01, followed by a one-month pause and then another one-month treatment with AKL-T01. The primary outcome measure of the study 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).
EndeavorRx (AKL-T01) is built on the Akili Selective Stimulus Management Engine (SSMETM) 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. This enables second by second monitoring of patient progress completing the treatment sessions, and continuously challenges each patient to an optimized level, encouraging patients to improve their performance. Driven by the core belief at Akili that effective medicine can also be fun and engaging, EndeavorRx is delivered through an action video game experience. The captivating experience of EndeavorRx is designed to drive engagement and compliance. To learn more about EndeavorRx, please visit www.EndeavorRx.com.
Akili is combining scientific and clinical rigor with the ingenuity of the tech and entertainment industries to challenge the status quo of medicine. Akili is pioneering the development of digital treatments and care solutions to help people affected by cognitive impairments. Akili’s treatments are designed to directly activate the networks in the brain responsible for cognitive function and have been rigorously tested in extensive clinical studies, including prospective randomized, controlled trials. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s treatments are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.
EndeavorRx™ is a registered trademark of Akili Interactive Labs, Inc.
1Kollins S.H., Heusser A., Lutz J. (2020, Oct 12-24). A Home-Based, Digital Treatment for Pediatric ADHD as Adjunct to Stimulant Medication: Insights on Repeat Administration and the Stability of Effects. [Conference poster]. Sixty-seventh Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP); Virtual.
2Childress, A.C., Lutz, J., Kollins, S.H. (2020, Oct 12-24). AKL-T01, a Digital Treatment for Pediatric ADHD as an Adjunct to Stimulant Medication: Response Rates with Repeat Administration. [Conference poster]. Sixty-seventh Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP); Virtual.
3Melmed R., Lutz J., Jina A. (2020, Oct 12-24). Improving Objective Measures of Attention in Test of Variables of Attention (TOVA) into Normative Ranges with AKL-T01, a Digital Treatment for Attention in Pediatric ADHD. [Conference poster]. Sixty-seventh Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP); Virtual.
4Davis N., Lutz J., Kollins S.H. (2020, Oct 12-24). AKL-T01, a Home-Based Digital Intervention as an Adjunct to Stimulant Medication for Pediatric ADHD: Academic Performance and Relation to Objective Measures of Attention. [Conference poster]. Sixty-seventh Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP); Virtual.