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Behavioural Intervention

Cognitive Training for Post-COVID-19 Cognitive Impairment

N/A

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Be older than 18 years old

Must not have

Known cognitive condition such as progressive dementia that would likely prevent the participant from responding to the effects of cognitive training or prevent them from being able to engage in self-consent

Non-English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial suggests that cognitive impairment is a common outcome for people who have had Covid-19, even if they were never hospitalized. It's not clear how Covid-19 causes cognitive impairment, but it's possible that the virus enters the brain directly or indirectly.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves cognitive training exercises, traditional physical side effects are unlikely. However, participants may experience frustration or fatigue from the mental tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not speak English.

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I cannot focus or think clearly enough to play games.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improve cognition

Side effects data

From 2023 Phase 2 trial • 110 Patients • NCT04843930

Dizziness

Nausea

Headache

Planned surgery

100%

80%

60%

40%

20%

Study treatment Arm

AKL-T01 Intervention

Waitlist Control

Control Arm Participants Who Started AKL-T01 Intervention

Control Arm Participants Who Declined AKL-T01 Intervention

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AKL-T01

2018

Completed Phase 2

~860

0 / 4Eligibility criteria met