COVID-19 gives Akili’s digital ADHD treatment an early debut in US

An app to treat children with attention-deficit hyperactivity disorder (ADHD) developed by Akili has been made available ahead of its FDA approval, under an agency scheme to speed up access to digital therapies during the coronavirus pandemic.

The app – called Endeavor (AKL-T01) – aims to improve children’s ability to focus by asking them to manage competing tasks and to shift attention between tasks using video game-like graphics and digital rewards.

Boston, US-based Akili, an affiliate of UK group PureTech Health, is still in the process of seeking FDA approval of the digital therapy as a prescription treatment. However, it has been able to offer it to children with ADHD and their families early because the FDA has relaxed regulations covering digital health devices for psychiatric conditions during the COVID-19 outbreak.

Just-published guidance from the regulator has introduced enforcement discretion for low-risk digital therapies that have clinical evidence to back up their efficacy, to support patients who may not be able to access their usual health services during lockdown.

Earlier this year, Akili reported the results of a randomised trial involving 348 children aged eight to 12 who played Endeavor or a control app for 25 minutes a day on weekdays for a month. They came off any ADHD medications before the study to stop these affecting the results.

By the end of follow-up, those playing Akili’s app reported a “meaningful” improvement in attention scores compared to the control app, said the clinical investigators, who reported their findings in The Lancet Digital Health.

There was no difference between the groups on secondary measures, and the researchers said that while the initial results were promising, additional studies are needed to support the routine use of the digital therapy for ADHD.

Lead investigator Scott Kollins of Duke University School of Medicine in the US says that while the coronavirus is making life hard for all children, it is particularly burdensome on those with ADHD.

 “Increased stress and upended schedules and routines have a direct impact on our cognition, increasing our distractibility and making it harder to stay focused and to be organised,” he explains.

“For children with attention issues associated with ADHD, their daily challenges are exacerbated and many of their support systems are no longer accessible.”

Akili is making Endeavor available to families with children diagnosed with ADHD and struggling with chronic attention issues – at no cost – for a limited time during the pandemic. It can be downloaded from Apple’s App Store.