Akili Interactive Labs (Akili) has begun enrolment for its STARS-ADHD trial, which will evaluate the safety and efficacy of the company's proprietary platform, Project: EVO, for the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD).
ADHD is a neurological condition marked by inattention and / or hyperactivity-impulsivity, and though about 75% of young children with ADHD receive medication, there is a growing demand for non-pharmacological interventions.
Project: EVO is designed to directly target an individual's core ability to process multiple streams of information, which has the potential to change specific neural networks and improve attention, inhibition and working memory.
STARS-ADHD is a double-blind, randomised, controlled, parallel-group, interventional trial that aims to enrol a minimum of 300 children aged eight to 12 years who have been diagnosed with ADHD.
Eligible individuals include those who are either not currently being treated with pharmaceutical interventions, or are being treated with a methylphenidate or amphetamine-based therapy and are willing and deemed appropriate to discontinue use for the duration of the study.
Participants will be enrolled at up to ten sites across the US, and use the intervention software at home on a tablet device for four weeks.
After the four-week period, an in-clinic evaluation will measure changes from baseline on a continuous performance test, a standard measure of attention and impulsivity.
Apart from this primary outcome, several secondary outcomes including those measuring symptom relief, memory, function and impairment will be examined.
Akili stated that in a recent open-label study, Project: EVO improved attention, inhibition and working memory in children with ADHD.
The company also aims to further validate the benefits of Project: EVO through the STARS-ADHD trial, which has been in piloting phase since November last year.
If the STARS-ADHD trial meets its endpoints, the company plans to seek approval from the US Food and Drug Administration (FDA) for this potential first-in-class treatment.
Akili co-founder and CEO Eddie Martucci said: "Project: EVO has demonstrated strong clinical potential in children with ADHD.
"The high-bar and rigour of a pivotal trial is an important next step toward clinically validating Project: EVO as a treatment.
"This validation is critical for doctors, patients and parents to have confidence in the safety and efficacy of this drug-free approach."