Akili Interactive Labs to launch ADHD clinical trial with eye on FDA clearance

By Aditi Pai
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Akili Interactive Labs will soon launch a clinical trial, called STARS-ADHD, that will evaluate the efficacy of its video game intervention for children with ADHD. The company plans to enroll a minimum of 300 children aged 8 to 12 years for its double-blind, randomized, controlled trial.

“Project: EVO has shown early promise to help improve attention and neurocognition in cognitive disorders like ADHD,” STARS-ADHD Principal Investigator Scott Kollins, who is a professor of psychiatry and the director of the ADHD Program at Duke University School of Medicine, said in a statement. “We look forward to enrolling patients and advancing the study and validation of this potential new treatment option for young patients with ADHD.”

Akili’s offering, a video game called Project: Evo, is based on research from UCSF. The game is designed to treat cognitive conditions. To play it, a user navigates an alien avatar, chosen specifically because it is culture-neutral but also relatable, down a course by tilting a mobile device back and forth. While navigating the alien, the user must also respond to targets by tapping the screen. The app keeps track of movements and can therefore monitor the user’s behavior and quickly adapt to the player.

Akili aims to recruit children to 10 sites across the US who either aren’t being treated with medication or are using a methylphenidate or amphetamine-based therapy and are able to halt treatment for the duration of the study. Participants will use the software on a tablet for four weeks at home. At that point, they will take an in-clinic assessment to measure changes from their baseline. The primary outcomes that will be measure in the trial are attention and impulsivity. Secondary outcomes include symptom relief, memory, function, and impairment.

If the STARS-ADHD trial, which has been in piloting phase since November, meets certain goals, the company will submit an application for an FDA clearance.

Akili Interactive Labs CEO and cofounder Eddie Martucci told MobiHealthNews in January that the company predicts it could receive its FDA clearance and bring the product to market by the end of 2017.

Akili has tested its product with a number of other cognitive conditions, including autism, Alzheimer’s, and depression. After receiving a clearance for ADHD, according to Martucci, the company will likely try to get clearance for the autism version, followed by depression and then Alzheimer’s.