Akili Interactive Labs has started recruiting patients for its pivotal 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).
Patients participating in the study will be asked to play the Project: EVO game that targets an individual's core ability to process multiple streams of information. By doing so, according to Akili, the app has the potential to change specific neural networks and improve attention, inhibition and working memory.
"Project: EVO has demonstrated strong clinical potential in children with ADHD," Eddie Martucci, Ph.D., Co-founder and CEO of Akili, said in a statement. "The high-bar and rigor 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."
STARS-ADHD is a double-blind, randomized, controlled, parallel-group, interventional trial which aims to enroll a minimum of 300 children aged 8 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, who will be enrolled at up to ten sites across the United States, will use the intervention software at home on a tablet device for 4 weeks. After the 4-week period, an in-clinic assessment will measure changes from baseline on a continuous performance test, a standard measure of attention and impulsivity. In addition to this primary outcome, several secondary outcomes –- including those measuring symptom relief, memory, function and impairment –- will be examined.
The trial aims to enroll a minimum of 300 children aged 8 to 12 years who have been diagnosed with ADHD.If the STARS-ADHD trial meets its endpoints, the company plans to seek approval from the US FDA for this potential first-in-class treatment.
Beyond ADHS, Akili has been conducting multiple clinical trials of its platform on patients with autism spectrum disorder (in collaboration with Autism Speaks), depression, Alzheimer's disease (in collaboration with Pfizer, Inc.) and traumatic brain injury, and it is also actively exploring clinical collaborations in other neurodegeneration indications.
Earlier this year, the company secured $30.5 million investment from JAZZ Venture Partners, Canepa Advanced Healthcare Fund and PureTech Health.