AKL-T01 is the first and only digital therapeutic specifically designed to improve attention function
Akili Interactive (“Akili” or “Company"), today announced collaborations with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate Akili digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19 (also known as “COVID brain fog”). There are currently no approved treatments for cognitive impairments in COVID-19 survivors.
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Screenshot of AKL-T01 gameplay (Graphic: Business Wire)
Under each collaboration, 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. AKL-T01 is the first and only digital therapeutic specifically designed to improve attention function. The organizations aim to begin clinical recruitment for the studies in the next month.
“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 S. Jina, M.D., Chief Medical Officer at Akili. “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.”
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 Drs. Abhishek Jaywant and Faith Gunning at Weill Cornell Medicine and NewYork-Presbyterian found that difficulties in attention, multitasking, and processing speed were common in hospitalized patients recovering from COVID-191. Of the patients in their study, 81% exhibited some degree of cognitive impairment1. 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 study2. For more information on COVID brain fog, click here.
“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 Ph.D., 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. “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 chronic symptoms of COVID-19 long haulers represent a serious and growing public health concern that will linger long after the acute nature of COVID-19 has passed,” said James Jackson, PsyD, Assistant Director of The ICU Recovery Center at Vanderbilt and lead psychologist for the Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center at the Vanderbilt University Medical Center. “We’re excited by the potential of new therapeutics that target cognitive impairments to help COVID-19 survivors.”
AKL-T01 is built on the Akili Selective Stimulus Management Engine (SSMETM), a disease agnostic proprietary technology designed to treat impaired cognitive function, specifically attention control. Delivered through an action video game experience, the first-in-class technology presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalize the treatment experience for each individual patient. SSME has been evaluated as a potential treatment for cognitive impairments associated with a number of different disease areas and has been studied in more than 2600 patients across 30 clinical trials. AKL-T01, branded EndeavorRxTM, is cleared for use by the U.S. Food and Drug Administration (FDA)3 and has received Conformité Européenne (CE) Mark certification in Europe for use in pediatric ADHD4. Product screenshots and b-roll are available here.
Study Designs
The Akili, Weill Cornell Medicine and NewYork-Presbyterian Hospital randomized, controlled study will evaluate AKL-T01 in approximately 100 COVID-19 survivors ages 18-89 who have exhibited a deficit in cognition. The study will take place over 10 weeks, with 6 weeks of treatment and 4 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. Secondary endpoints include additional measures of cognitive functioning. The study will be conducted remotely in patients’ homes, and patients in the control arm will have the option to receive the AKL-T01 intervention after the conclusion of their participation in the control condition.
The Akili and Vanderbilt randomized, controlled study will evaluate AKL-T01 in approximately 100 COVID-19 survivors ages 18 and older who have exhibited a deficit in cognition. The study will recruit from subjects who have completed the SARS-CoV-2 Household Transmission Study. Half of the study participants will receive the digital treatment for 4 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 (composite score of cognitive function, especially attention and processing speed). Secondary endpoints include additional measures of cognitive functioning. The study will be conducted remotely in patients’ homes.
About Akili
Akili is combining scientific and clinical rigor with the ingenuity of the tech and entertainment industries to challenge the status quo of medicine. Akili has pioneered the development of video game-based digital medicine to improve cognitive function. Akili’s flagship product is a prescription digital treatment to address inattention in children with attention deficit hyperactivity disorder (ADHD). Akili’s patented technology serves as the foundation of its products and is designed to directly activate the networks in the brain responsible for cognitive function. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s treatments are delivered through captivating action video game experiences that drive engagement and compliance. For more information, please visit AkiliInteractive.com.
1 Jaywant et al. Neuropsychopharmacol. (2021).
2 David et al. Preprint. (2020).
3 EndeavorRx is an FDA-cleared medical device. It is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication.
4 In June 2020, EndeavorRx received Conformité Européenne (CE) Mark certification as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with ADHD.
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Contacts
Julie DiCarlo
julie@akiliinteractive.com
