Akili Achieves Primary Efficacy Endpoint in ADHD Trial (MD magazine):
“Boston-based Akili Interactive has announced top-line results from the STARS-ADHD pivotal study of its investigational digital therapeutic medicine AKL-T01, in treatment of pediatric attention-deficit/hyperactivity disorder (ADHD)…The digital medicine, AKL-T01, is a video game for patients to play on tablet devices. It uses the same storytelling and reward mechanisms as standard videogames; however, it features mechanisms to act on neural systems and algorithms that dial the level of stimulus up or down, meeting the needs of the patient.
In the STARS-ADHD randomized, controlled trial of 348 children and adolescents diagnosed with ADHD, AKL-T01 showed a statically significant improvement compared to an active control group on the predefined primary endpoint, a change in the Attention Performance Index (API), a composite score from the Test of Variables of Attention (TOVA)…
After the 4‑week period, an assessment measured changes from baseline on standard measures of attention, memory and impulsivity. Children and adolescents that received AKL-T01 showed a statistically meaningful improvement in attentional functioning on the API…Engineered as a therapeutic active treatment for cognitive deficiency, AKL-T01 is built on Akili’s patented Project: EVO technology platform that allows selective targeting and activation of specific cognitive neural systems in the brain that exhibit deficiency from various medical conditions…
Akili plans to file for regulatory approval with the US Food and Drug Administration in the first half of 2018 for clearance as a novel treatment for children and adolescents with ADHD, paving the way for the first ‘digital’ prescription product to directly treat a disorder.
The company is also studying whether a similar version of its video game could potentially treat adults with depression, and the Akili recently started a mid-stage clinical trial with early results expected late next year.”
The Study (ongoing)
Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) (ClinicalTrials.gov)
- Purpose: The purpose of this study is to evaluate the effects of videogame-like digital therapies on attentional functioning and symptoms in children diagnosed with ADHD.
- Official title: A Randomized, Controlled, Parallel-group, Intervention Study to Assess At-home, Game-based Digital Therapy for Treating Pediatric Participants Ages 8 to 12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
- Detailed description: The study will be a randomized, parallel group, controlled trial of two videogame-like (iPad-based) digital therapies. The study will consist of 3 primary phases: Screening, Washout/Baseline, and Treatment. During the Screening Phase (Day ‑28 to Day ‑7), participants will undergo screening to evaluate eligibility for the study. Screening may take place up to 28 days before the Baseline Visit (Day 0). For those children currently on medication for ADHD the Washout period will begin 7 days prior to Baseline where treatment will be discontinued. On Day 0, the Baseline visit will occur wherein additional eligibility criteria will be established. The Treatment Phase (Day 1 to Day 27) will involve using the digital therapy at home for each participant followed by an In-Clinic assessment on Day 28 to assess key outcomes. Compliance with treatment/use requirements will be monitored remotely during this phase.
- Just announced top-line results: HERE
The Study in Context
- Johns Hopkins study shows how brain training, if correctly targeted, can enhance cognitive and brain performance
- Can brain training work? Yes, if it meets these 5 conditions
- What are cognitive abilities and how to boost them?
- Solving the Brain Fitness Puzzle Is the Key to Self-Empowered Aging
- Five reasons the future of brain enhancement is digital, pervasive and (hopefully) bright
- We discuss the findings with Akili’s CEO Dr. Eddie Martucci at the 2017 SharpBrains Virtual Summit: Brain Enhancement in the Digital Age (December 5–7th, 2017)