Cognitive Training for Post-COVID-19 Cognitive Impairment

Overseen By Rebecca Abel, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Non-English, Incarcerated, Blind, Dementia, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital treatment, AKL-T01, an engaging video game app designed to improve thinking skills in individuals who have experienced cognitive difficulties after Covid-19. The researchers aim to determine if this app can effectively boost brain function for those facing Covid-19-related cognitive challenges. Participants will either use the app or serve as a control group without any intervention for comparison. Suitable candidates are those who have tested positive for Covid-19 and experience memory or concentration issues. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to new methods of enhancing cognitive recovery after Covid-19.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cognitive training program is safe?

Research shows that AKL-T01, a digital therapy delivered through a video game, has undergone safety testing. Initially approved for children with ADHD, it has demonstrated a degree of safety for humans. Studies have found it improves attention and thinking skills, reporting no major safety problems. Most participants tolerated the treatment well, experiencing no serious side effects. This suggests that AKL-T01 is likely safe for individuals with cognitive issues after COVID, though ongoing research will provide more definitive answers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AKL-T01 because it offers a novel, digital approach to tackling post-COVID-19 cognitive impairment. Unlike traditional cognitive therapies that may involve medication or in-person therapy sessions, AKL-T01 is a video game-based software delivered through an app on an iPad. This method not only makes the treatment more engaging and accessible but also allows for targeted cognitive training in a convenient, at-home setting. This innovative approach leverages technology to potentially improve cognitive function in a fun and interactive way, which could be a game-changer for patients struggling with cognitive issues after COVID-19.

What evidence suggests that AKL-T01 is effective for post-COVID-19 cognitive impairment?

Research has shown that AKL-T01, a digital treatment delivered through a video game, might help with cognitive issues like brain fog in people who have had COVID-19. In this trial, participants in the intervention arm will use this game-based software, which has improved attention and mental control, important thinking skills. The treatment is designed to be fun and can be used on an iPad, making it easy to use at home. Studies are examining how well this treatment works for those dealing with cognitive problems after COVID-19. AKL-T01 has also been used to help kids with ADHD, showing promise for improving focus and thinking skills. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had COVID-19 and are now experiencing cognitive issues, confirmed by specific tests. It's not for those with pre-existing conditions like progressive dementia, non-English speakers, or individuals with severe impairments that prevent game interaction.

Inclusion Criteria

You have tested positive for COVID-19 before the start of the study.

You have a noticeable problem with memory and thinking, as measured by specific tests.

Exclusion Criteria

Previous enrollment in a study using AKL-T01

I cannot play the game because of my physical disability.

I do not have a cognitive condition that prevents me from understanding or consenting to treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the digital app-based intervention AKL-T01 to improve cognition

4 weeks

Virtual sessions

Follow-up

Participants are monitored for cognitive improvements and safety after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AKL-T01

Trial Overview The study is testing AKL-T01, a cognitive training program against a control group to see if it helps improve brain function in people who have had COVID-19 and are facing mental challenges.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The study intervention, AKL-T01 (Akili Interactive), is a digital, app-based intervention designed to target and improve cognition through an engaging video game-based software experience delivered on an iPad.

Group II: Placebo Placebo Group 1 Intervention

Patients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. akiliinteractive.com akiliinteractive.com/covid-brain-fog

COVID Brain Fog We are working with leading academic researchers to study AKL-T01 as potential treatment for patients with COVID brain fog.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04843930

NCT04843930 | Improving Cognitive Health in COVID-19 ... The primary objective of this study is to investigate the efficacy of AKL-T01, a remotely-delivered digital cognitive intervention, relative to a waitlist ...

3. akiliinteractive.com akiliinteractive.com/news-collection/akili-collaborates-with-weill-cornell-medicine-newyork-presbyterian-hospital-and-vanderbilt-university-medical-center-to-study-digital-therapeutic-akl-t01-as-treatment-for-covid-brain-fog

Akili Collaborates with Weill Cornell Medicine, NewYork- ... The Akili and Vanderbilt randomized, controlled study will evaluate AKL-T01 in approximately 100 COVID-19 survivors ages 18 and older who have ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39358543/

A digital intervention for cognitive deficits following COVID-19 AKL-T01 is a digital therapeutic using a videogame interface to target attention and executive control. The intervention was delivered remotely ...

5. statnews.com statnews.com/2021/04/07/akili-endeavorrx-covid19-brain-fog/

Akili's therapeutic game will be tested as a treatment for Covid ... Two studies will test whether Akili's EndeavorRx game, cleared for use in kids wtih ADHD, can help adults suffering from Covid “brain fog.”

6. psypost.org psypost.org/therapeutic-video-game-shows-promise-for-post-covid-cognitive-recovery/

Therapeutic video game shows promise for post-COVID ... A new study finds that a therapeutic video game, AKL-T01, improved task-switching and processing speed in people with post-COVID cognitive ...