Covid19NCT04956887
Cognitive Training in Survivors of Covid-19: A Randomized Trial
A study testing AKL-T01 in people with Covid19 and Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Cognitive Impairment
- What is being tested?
- AKL-T01
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Laboratory-confirmed SARS-CoV-2 infection prior to randomization (we will track the specific date at which Covid-19 was diagnosed)
- Presence of objective cognitive impairment (less than 18 on the MOCA-Blind) and/or the presence of subjective cognitive decline via the IQCODE-Short Form, as reflected in a score greater than 3.3.
Who cannot join
- Non-English speaking
- Incarcerated
- Blind/ color blind
- Unable to play the game due to a physical disability
- Unable to play the game due to severe cognitive impairment (e.g., too inattentive or delirious) prior to randomization.
- A 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.
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- Previously enrolled in a study using AKL-T01
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
- Any other clinical condition that would jeopardize patient's safety while participating in this trial or may prevent the patient from adhering to the trial protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
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).
Read the detailed description
As the Investigators have described, a frequent and particularly disabling consequence of Covid-19 may be in the cognitive arena, with deleterious implications for employment, quality of life, and other dimensions of functioning. As such, efforts to develop interventions aimed at improving neuropsychological outcomes are important and a key feature of an overarching public health strategy. One potential intervention of interest is cognitive training, which has been employed with increasing success with wide-ranging populations, though only minimally with survivors of critical illness and not with Covid-19 patients at all. Cognitive training, particularly the kind that relies on what are known as digital interventions (programs which, functionally, look like video games) is particularly appropriate in the pandemic climate, as it can be done entirely in a virtual contactless fashion, thus decreasing the risk of infection. The Investigators propose a pilot study in 100 cognitively impaired community dwelling patients who tested positive for Covid-19 and are participants in an existing study/ongoing study of household transmission of Covid-19 (the SARS-Co-V-2 Household Transmission Study, with the following specific aim and hypotheses:
Study Aim: To evaluate the feasibility of conducting a randomized trial evaluating the effectiveness of a digital app-based intervention (AKL-T01) to improve 4-week cognition (post-intervention) in cognitively impaired survivors of Covid-19.
Hypothesis 1: A trial evaluating AKL-T01 for improving long-term cognition in community dwelling and cognitively abnormal COVID-19 patients will be feasible, as denoted by achieving each of the following in this pilot trial: (a) recruitment and successful protocol completion of up to 100 patients; (b) successful completion of 4-week cognitive assessments by >80% of survivors; and (c) the primary cognitive outcome (a composite score on CNS Vital Signs) numerically favoring the intervention group with the one-tailed upper 80% confidence interval of the difference in a composite outcome between the intervention and placebo groups containing the minimally-important clinical difference on a CNS Vital Signs composite measure.
- Conditions
- Covid19, Cognitive Impairment
- Being tested
- AKL-T01, Control Group
- Medical subject headings
- COVID-19, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKL-T01Behavioural
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.
Control GroupOther
Patients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: AKL-T01 |
| Placebo | Placebo comparator | Patients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve cognition
To evaluate the feasibility of conducting a randomized trial evaluating the effectiveness of a digital app-based intervention (AKL-T01) to improve 4-week cognition (post-intervention) in cognitively impaired survivors of Covid-19.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start3 Aug 2021
- Primary completion31 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the patient or authorized surrogate provides informed consent, the cognitive training and rehabilitation intervention versus usual care will be randomly assigned at a 1:1 allocation ratio. Computerized randomization will occur after informed consent has been obtained using a permuted-block randomization scheme with varying block size. We will use adequate allocation concealment using a computer-generated, permuted-block randomization scheme with varying block size. The block size and randomization list will only be known to the independent biostatistician creating the randomization list and will not be shared with trial investigators or any other study personnel, as this information could make it easier to correctly guess the next treatment allocation. This list will be directly uploaded into REDCap's randomization module.16
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James C. Jackson, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956887
- Sponsor's protocol ID
- 210121
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Survivors of Covid-19: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04956887
- Acronym / sponsor ID
- 210121
- Conditions
- Covid19, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
As the Investigators have described, a frequent and particularly disabling consequence of Covid-19 may be in the cognitive arena, with deleterious implications for employment, quality of life, and other dimensions of functioning. As such, efforts to develop interventions aimed at improving neuropsychological outcomes are important and a key feature of an overarching public health strategy. One potential intervention of interest is cognitive training, which has been employed with increasing success with wide-ranging populations, though only minimally with survivors of critical illness and not with Covid-19 patients at all. Cognitive training, particularly the kind that relies on what are known as digital interventions (programs which, functionally, look like video games) is particularly appropriate in the pandemic climate, as it can be done entirely in a virtual contactless fashion, thus decreasing the risk of infection. The Investigators propose a pilot study in 100 cognitively impaired community dwelling patients who tested positive for Covid-19 and are participants in an existing study/ongoing study of household transmission of Covid-19 (the SARS-Co-V-2 Household Transmission Study, with the following specific aim and hypotheses:
Study Aim: To evaluate the feasibility of conducting a randomized trial evaluating the effectiveness of a digital app-based intervention (AKL-T01) to improve 4-week cognition (post-intervention) in cognitively impaired survivors of Covid-19.
Hypothesis 1: A trial evaluating AKL-T01 for improving long-term cognition in community dwelling and cognitively abnormal COVID-19 patients will be feasible, as denoted by achieving each of the following in this pilot trial: (a) recruitment and successful protocol completion of up to 100 patients; (b) successful completion of 4-week cognitive assessments by >80% of survivors; and (c) the primary cognitive outcome (a composite score on CNS Vital Signs) numerically favoring the intervention group with the one-tailed upper 80% confidence interval of the difference in a composite outcome between the intervention and placebo groups containing the minimally-important clinical difference on a CNS Vital Signs composite measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After the patient or authorized surrogate provides informed consent, the cognitive training and rehabilitation intervention versus usual care will be randomly assigned at a 1:1 allocation ratio. Computerized randomization will occur after informed consent has been obtained using a permuted-block randomization scheme with varying block size. We will use adequate allocation concealment using a computer-generated, permuted-block randomization scheme with varying block size. The block size and randomization list will only be known to the independent biostatistician creating the randomization list and will not be shared with trial investigators or any other study personnel, as this information could make it easier to correctly guess the next treatment allocation. This list will be directly uploaded into REDCap's randomization module.16
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: AKL-T01The 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. |
| Placebo | Placebo comparator | Other: Control GroupPatients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Laboratory-confirmed SARS-CoV-2 infection prior to randomization (we will track the specific date at which Covid-19 was diagnosed)
- Presence of objective cognitive impairment (less than 18 on the MOCA-Blind) and/or the presence of subjective cognitive decline via the IQCODE-Short Form, as reflected in a score greater than 3.3.
Key exclusion criteria (9 listed)
- Non-English speaking
- Incarcerated
- Blind/ color blind
- Unable to play the game due to a physical disability
- Unable to play the game due to severe cognitive impairment (e.g., too inattentive or delirious) prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKL-T01The 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. | Behavioural | Intervention |
| Control GroupPatients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning | Other | Placebo |
Primary outcome
Improve cognition
Time frame: 4 weeks
To evaluate the feasibility of conducting a randomized trial evaluating the effectiveness of a digital app-based intervention (AKL-T01) to improve 4-week cognition (post-intervention) in cognitively impaired survivors of Covid-19.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKL-T01 in people with Covid19 and Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve cognition (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.