Health IT

Akili Labs recruits for ADHD trial with ambitions of FDA clearance for digital medicine

Akili Labs has kicked off open enrollment for a clinical trial of its Project EVO  video game platform in a quest to secure for 510(k) clearance from the U.S. Food and Drug Administration for its lead indication — attention deficit hyperactivity disorder. The trial is recruiting at least 300 participants aged 8-12 years old who […]

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Akili Labs has kicked off open enrollment for a clinical trial of its Project EVO  video game platform in a quest to secure for 510(k) clearance from the U.S. Food and Drug Administration for its lead indication — attention deficit hyperactivity disorder.

The trial is recruiting at least 300 participants aged 8-12 years old who have been diagnosed with ADHD. It will evaluate the safety and efficacy of the Project EVO platform, according to a company statement. The ultimate goal is to provide a drug alternative for children with ADHD and  Akili Labs CEO Eddie Martucci views digital therapeutics as the way to do that. The game is designed to improve the ability of kids with ADHD to process multiple streams of information, improve attention, inhibition and working memory.

If the trial meets its endpoints, the company plans to submit Project EVO for FDA approval.

In a phone interview in February Martucci said, “We want this to stand alongside Adderall and other drugs as a doctor-prescribed treatment.”

This is how the trial will work. The trial will be set up at 10 sites across the U.S.. Participants will use Project EVO on a tablet at home over a four-week period. An assessment will assess changes between the participant’s baseline performance and look for any improvements through completion of a continuous performance test for attention and impulsivity

The video game’s underlying platform was developed at the University of California at San Francisco in the labs of Dr. Adam Gazzaley. The game generates a baseline for each user and is designed to automatically adjust to the player’s functional level, whether they are a 70-year-old with a cognitive impairment or a 10 year-old with ADHD.

The hope is that the gaming platform can function as a digital therapeutic not only for ADHD, but also for people with traumatic brain injury, neurodegenerative disorders and pediatric applications.