Startup collaborates with NewYork-Presbyterian, Vanderbilt to test video game therapy for COVID 'brain fog'

Akili Interactive's digital therapeutic, AKL-T01, which is commercially marketed as EndeavorRx, provides challenges and stimuli that target the brain’s neural systems linked to focus, cognitive function and multitasking. (Akili Interactive)

A startup is working with major academic medical centers to study whether a therapeutic video game can help patients suffering from "COVID brain fog."

Although not a clinical term, brain fog is a phrase being used to describe the lingering mental and cognitive effects felt by people who had COVID-19. Some people with COVID-19 report having brain fog for weeks or months after their respiratory symptoms pass.

Boston-based Akili Interactive is collaborating with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate the company's digital therapeutic, AKL-T01, as a treatment for patients with cognitive dysfunction following COVID-19.

The company develops video game-based digital therapeutics to improve cognitive function. Akili’s flagship product is a prescription digital treatment, AKL-T01, to address inattention in children with attention deficit hyperactivity disorder (ADHD).

Akili made headlines last summer when that therapeutic, which Akili commercially markets as EndeavorRx, was cleared for use by the U.S. Food and Drug Administration (FDA) as the first prescription video game treatment for children with ADHD.

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The software provides challenges and stimuli that target the brain’s neural systems linked to focus, cognitive function and multitasking. 

Akili will work with research teams at each institution to conduct two separate randomized, controlled clinical studies evaluating AKL-T01’s ability to target and improve cognitive functioning in COVID-19 survivors who have exhibited a deficit in cognition. The organizations aim to begin clinical recruitment for the studies in the next month.

There are currently no approved treatments for cognitive impairments in COVID-19 survivors, according to Akili. 

“As frontline healthcare workers continue to fight the immediate acute symptoms of COVID-19, certain longer-term consequences of the illness are beginning to emerge, including serious cognitive impairments,” said Anil Jina, M.D., chief medical officer at Akili, in a statement.

"With more than 100 million infections globally and counting, the potential impact of long-term cognitive impairments in even a subset of these patients is devastating. We look forward to working with leading researchers at Vanderbilt, Weill Cornell and NewYork-Presbyterian to understand and improve COVID-19-related cognitive deficits," Jina said.

Since being named a global pandemic by the World Health Organization in March 2020, clinicians continue to learn about the vast ways in which COVID-19 manifests in patients. Evidence is mounting on long-term neurological and cognitive symptoms that can persist in some COVID-19 patients after initial diagnosis, even after the virus is no longer detected in the body.  

A study published in Neuropsychopharmacology led by Abhishek Jaywant, Ph.D., and Faith Gunning, Ph.D., at Weill Cornell Medicine and NewYork-Presbyterian found that difficulties in attention, multitasking and processing speed were common in hospitalized patients recovering from COVID-19. Of the patients in their study, 81% exhibited some degree of cognitive impairment.

Recent research also shows these cognitive impairments may persist post-hospitalization and commonly occur in “post-COVID long haulers” or “long COVID” patients. These impairments can have a significant impact on survivors’ daily functioning and quality of life, impacting the ability of most COVID-19 long haulers to work for six months or more according to a recent study.

“Clinicians are seeing an increase in cognitive impairments among COVID-19 patients and though we don’t yet know how long these difficulties last, we are concerned about how these cognitive difficulties may affect people in their daily lives,” said Gunning, vice-chair of research in the Department of Psychiatry, associate professor of psychology in psychiatry at Weill Cornell Medicine and associate attending psychologist at NewYork-Presbyterian/Weill Cornell Medical Center, who is the study coordinator.

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“It’s critical that we identify therapeutics to help the increasing number of people whose lives have been impacted by cognitive impairments associated with COVID-19.”

The Weill Cornell-NewYork-Presbyterian study will evaluate 100 individuals aged 18-89 who have recovered from COVID-19 and have exhibited a deficit in cognition. The study will take place over 10 weeks, with six weeks of treatment and four weeks of follow-up. Half of the study participants will receive the digital treatment and half will serve as a control group. The primary endpoint of the study is mean change in cognitive function, as assessed by a measure of attention and processing speed, they said.

For the study at Vanderbilt, 100 COVID-19 individuals who have recovered from COVID-19 and have exhibited a deficit in cognition also will be evaluated. Half of the study participants will receive the digital treatment for four weeks, and half will serve as a control group. The primary endpoint of the study is mean change in cognitive function as measured by CNS Vital Signs.

Both studies will be conducted remotely in patients’ homes.