Akili, which made history last summer by earning regulatory clearance for the first video-game based therapy, now plans to test if its software can help adults suffering from Covid “brain fog.”
Two randomized remote studies, one conducted by Weill Cornell Medicine and New York-Presbyterian Hospital and the other by Vanderbilt University Medical Center, will assess whether AKL-T01, the treatment that Akili commercially markets for ADHD as EndeavorRx, can help improve cognition symptoms in Covid survivors.
The new studies come at a pivotal moment for Akili. EndeavorRx is being prescribed by more doctors, but the company is still hoping for widespread acceptance. As Akili labors to show EndeavorRx works, it’s also looking for new pathways to commercialization.
“The technology that we have at Akili is not very specific to one disease area,” Anil S. Jina, the company’s chief medical officer, told STAT. “It basically improves attention control, which is one of the aspects of cognition, and that is part and parcel of many different disorders.”
He said that while childhood ADHD made sense as an early commercial target, independent investigators have done many small studies on the underlying technology’s efficacy in treating adults for a range of cognitive conditions, including dementia and mild cognitive impairment.
Akili had an existing relationship with the researchers at Cornell, and late last year, Jina got an early look at data from their research on cognitive impairment in Covid-19 patients. He said that so-called Covid brain fog — an imprecise term that’s used to describe difficulty paying attention, memory loss, and a variety of other cognitive symptoms in Covid survivors — lined up with areas of cognitive impairment that Akili’s system has been effective in treating.
The link between Covid-19 infection and cognitive impairment remains unclear, but preliminary research published by the Cornell researchers is alarming. In a cohort of 57 patients in rehab following hospitalization for Covid, 81% had some cognitive impairment, 55% showed deficits in working memory, and 46% experienced divided attention. Faith Gunning, an associate professor of psychology at Weill Cornell Medicine and vice chair of research in Cornell’s psychiatry department, cautions that the study is a snapshot of the very sickest people immediately after they were in the hospital.
“We don’t expect that level of cognitive difficulty to persist in many of the people as time progresses,” she said. “I think there will be a subset that will have residual cognitive complaints and and perhaps even objective cognitive difficulties.
Still, given the prevalence of people reporting cognitive issues after Covid infection, the potential lasting impact is tremendous, and points to how a solution like Akili’s treatment could be helpful.
“I don’t think we are going to have the manpower in our healthcare system to do in-person cognitive remediation with the number of people who may need it,” said Gunning.
The Cornell-NewYork-Presbyterian and Vanderbilt studies are designed slightly differently, but share a number of the same parameters. They will both include roughly 100 Covid-19 survivors over 18 who show some measurable cognitive impairment. Half of patients in both studies will receive treatment and half will serve as control. The treatment protocol calls for patients to complete five missions per day five times a week. A day’s worth of missions takes about 25 minutes. The protocol mirrors the one used in Akili’s pivotal study for EndeavorRx as well as for a recently published adjunct study.
The Cornell study will run for six weeks with four weeks of post-treatment follow up. The Vanderbilt study will end after a four-week treatment. Both studies will evaluate patients on several cognitive measurements.
The decisions on study design were rooted in the specializations of each center and other practical considerations, but Jina said it also reflects the early stage of the research.
“We’re learning what Covid fog is and what the patients are exhibiting and what longer term outcomes are day-by-day as we’re going,” he said. “So I wanted to spread out our research net a little bit wider.”
James Jackson, assistant director of the ICU Recovery Center at Vanderbilt, said the impairment demonstrated by people Covid-19 is consistent with many long-term studies looking at people after they’ve been in intensive care, and he expects there to be lasting impacts in the population.
“I suspect when the dust settles, thoughtful people will reflect on the fact that one of the signature injuries, if you will, of Covid-19 is cognitive deficits and cognitive impairment,” said Jackson, who is also the lead psychologist for the Critical Illness, Brain Dysfunction and Survivorship Center at Vanderbilt University Medical Center,
Though Covid-19 is a singular illness, Jackson said, researchers studying how to deal with its effects aren’t totally in the dark. Many evidence-based treatments, including Akili’s tech, are designed to target similar symptoms of cognitive impairment in other conditions.
“Thankfully, a lot of the modalities that we’ve developed… whether it would be for PTSD or whether it would be for attention, until we become convinced otherwise, I think most of us imagine that they’re going to be effective and we’re hopeful,” he said.