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

83 Participants Needed

Trial Summary

What is the purpose of this trial?

Preliminary evidence suggests that cognitive impairment is a common outcome experienced by individuals surviving Covid-19 (1-5). Cognitive impairment following Covid-19 which leads to critical illness is not surprising and perhaps even expected. However, significant cognitive deficits appear to be common even among individuals testing positive for Covid-19 who were never hospitalized. Questions exist regarding the mechanisms of the aforementioned cognitive impairment. The association between COVID-19 and brain dysfunction is not surprising since SARS-CoV has been found in the brain and because Coronaviridaes (CoVs) have been associated with central nervous system (CNS) diseases such as acute viral encephalopathy, acute disseminated encephalomyelitis, and multiple sclerosis (6-11).The possible brain entry routes for CoVs include either direct intranasal access to the brain via olfactory nerves or indirect access by crossing the blood-brain barrier (BBB) via hematogenous or lymphatic spread (9).

Eligibility Criteria

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

I am 18 years old or older.

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.

Treatment Details

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.

Participant Groups

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+