7 April 2021 - - US-based prescription digital medicine company Akili Interactive has forged collaborations with Weill Cornell Medicine, New York-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.

There are currently no approved treatments for cognitive impairments in COVID-19 survivors.

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.

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 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.

AKL-T01 is built on the Akili Selective Stimulus Management Engine (SSME), 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 EndeavorRx, is cleared for use by the US Food and Drug Administration 3 and has received Conformité Européenne Mark certification in Europe for use in pediatric ADHD4.

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.

Akili's flagship product is a prescription digital treatment to address inattention in children with attention deficit hyperactivity disorder. 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.