Though it’s currently cleared by the FDA to lessen attention-deficit/hyperactivity disorder (ADHD) symptoms only in children between the ages of 8 and 12, Akili Interactive’s EndeavorRx digital therapeutic may actually be even more effective among older users.
A recent study of the video-game-based treatment that focused on adults with ADHD found that EndeavorRx boosted their sustained and selective attention at a rate nearly seven times that of the improvements seen in the original, younger test group, according to top-line study results announced Wednesday.
Though the full data set has yet to be published, Akili said it plans to present it at a future scientific meeting and to submit the findings to the FDA later this year. In the company's announcement, Chief Medical Officer Scott Kollins, Ph.D., suggested the game-based treatment could fill a gap in the market for non-drug ADHD therapies for adults, a group that has seen growing numbers of diagnoses in recent years.
The open-label study recruited a total of 221 adults who had been diagnosed with ADHD, about 70% of whom were women. They were tasked with using the EndeavorRx program on a mobile device at home for six weeks; the digital treatment aims to improve attention and other ADHD-related symptoms by guiding users through a multilevel interactive game filled with sensory stimuli and motor challenges.
To measure the study’s primary endpoint, the users’ attention levels were evaluated before and after the study period using the Test of Variables of Attention-Attention Comparison Score computerized test, known as TOVA-ACS. After six weeks of treatment, EndeavorRx’s adult users saw their TOVA-ACS scores improve by an average of nearly 6.5 points, well beyond the 2.6-point improvement seen in a recent study of teenagers and the 0.9-point boost achieved among 8- to 12-year-olds.
Altogether, 83% of the adult users experienced a “clinical response” to the treatment, defined as an improvement of at least 1.4 points on the TOVA-ACS test. Akili noted in the results that EndeavorRx’s effects were largely consistent across both the 40% of participants who were also taking prescription medication for their ADHD and those who weren’t.
Alongside their improved attention, about a third of the participants saw their other ADHD symptoms improve by at least 30%, according to the ADHD Rating Scale-5—again, a noticeably larger improvement than the 27% of teens and 24% of kids who achieved similar reductions.
Many of the users also saw their quality of life improve, with more than 70% citing at least some improvement on the Adult ADHD Quality of Life Scale and almost half achieving clinically meaningful improvements. According to Akili, those improvements translate into an increased ability to stay on top of projects and tasks and to keep track of personal items.
Though none of the study participants reported any serious adverse events associated with their use of EndeavorRx, 11 of them did experience side effects, the most common of which were nausea and headache.
The successful study results come amid a rather rocky period for Akili. The recently public company kicked off 2023 with the announcement that it would lay off 46 workers, or about a third of its total workforce.
The cost-cutting moves also included plans to halt studies of EndeavorRx beyond ADHD; Akili had previously planned to expand the digital therapeutic into lupus, autism, multiple sclerosis, depression, general cognitive monitoring and more.
The slim-down came as Akili racked up just $323,000 in total revenues for 2022—all of which came from EndeavorRx product revenue—against more than $90 million in operating expenses. The company’s stock has similarly struggled: After going public at a share price above $14 last September, it plummeted to an all-time low of 97 cents at the end of the year. The shares have spent 2023 largely bouncing between $1 and $2, and, after clocking several weeks around the lower end of that range, scored a 37% overnight boost, to $1.49, with the release of the study results Wednesday morning.