Improving Cognitive Health in COVID-19 Survivors

February 26, 2024 updated by: Weill Medical College of Cornell University

Improving Cognitive Health in COVID-19 Survivors Through Digital Therapeutics

The primary objective of this study is to investigate the efficacy of AKL-T01, a remotely-delivered digital cognitive intervention, relative to a waitlist control in improving cognitive functioning in COVID-19 survivors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Emerging evidence suggests a subgroup of survivors of COVID- 19 have residual difficulties with cognition and daily functioning. These deficits are pronounced in cognitive domains including attention, learning and executive skills, and may continue to impact quality of life after recovery from other COVID-19 symptoms. This study aims to investigate the efficacy of AKL-T01 (Akili Interactive), a remotely-delivered digital cognitive intervention, in targeting and improving cognition and functional outcomes in individuals recovering from COVID-19. The efficacy of the AKL-T01 intervention will be measured relative to a waitlist control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female 18-89 years of age
  • Documentation of a deficit in cognitive function (score > 1 standard deviation below normal range) compared to age-adjusted normative data) on at least one screening measure of attention and executive function (Oral Trail Making Test, Stroop Test, or FrSBe)
  • Previous diagnosis of COVID-19 confirmed via SARS-CoV-2 polymerase chain reaction (PCR) test (or reported experience of COVID-19 symptoms with a documented positive antibody test or clinical diagnosis based on symptoms and accompanying physician's note) documented in the electronic medical record or in other existing medical records
  • Access to and self-report of ability to connect wireless devices to a functional wireless network.
  • Ability to follow written and verbal instructions (English) as assessed by the PI and/or coinvestigator.
  • Able to comply with all testing and study requirements and willingness to participate in the full study duration

Exclusion Criteria:

  • History of neurologic disorder prior to COVID-19 diagnosis, such as Parkinson's disease, multiple sclerosis, Alzheimer's disease, stroke, brain tumor, or dementia.
  • History of severe mental illness (e.g., schizophrenia, psychosis, history of suicide attempt in the last year) or substance use disorder, recent history (in the past year) of symptoms of psychosis
  • Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior.
  • Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator
  • Recent history (within 6 months prior to screening/baseline) of substance use disorder
  • History of seizures (excluding febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
  • Color blindness as determined by self-report
  • Regular use of psychoactive drugs other than antidepressants or benzodiazepines, including stimulants that in the opinion of the Investigator may confound study data/assessments.
  • Any other acute medical condition that may interfere with participation or interpretation of the results
  • Previous exposure to AKL-T01.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AKL-T01 Intervention
Participants in the experimental group will complete 6 weeks of the AKL-T01 intervention. Participants enrolled in the intervention arm will play the game via an iPad application for 20-25 minutes daily for at least 5 days a week (but up to 7 days a week). Participants will also have weekly check-in visits via phone or a secure HIPAA compliant videoconferencing platform (Zoom) with a care manager, who will monitor mood symptoms and gameplay adherence.
Device: AKL-T01
AKL-T01 will be administered as a 6-week intervention. It is an algorithmically delivered iPad-based video game designed to improve cognitive health by targeting attention and attentional control processes.
No Intervention: Waitlist Control
Participants in the Waitlist Control arm will not be engaging in any active control condition. Participants in the waitlist control arm will continue any ongoing self- or provider-based cognitive intervention (or no intervention) during the initial 6-week waitlist period. Participants will also have weekly check-in visits via phone or a secure HIPAA compliant videoconferencing platform (Zoom) with a care manager, who will monitor mood symptoms. The control arm will be offered the intervention at the end of 6 weeks waitlist period to ensure all participants ultimately have access to the intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task
Time Frame: Baseline and Post Treatment (6 weeks)
Change in cognitive function in the experimental group vs. controls, measured by score on the Digit Symbol Matching Task, a timed measure of attention and processing speed. Participants are asked to correctly match pairs of shapes and numbers. Scores exceeding the normative mean number correct (mean = 65.79) reflect better task performance and scores below the normative mean reflect poorer performance.
Baseline and Post Treatment (6 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale
Time Frame: Baseline and Post Treatment (6 weeks)
Change in scores on the NeuroQOL Cognitive Function scale in the experimental group vs. controls. The NeuroQOL Cognitive Function scale is a 28-item self-report measure of daily functioning. Higher scores, defined as those exceeding the population mean (mean (SD) = 50.09 (10.23)), reflect better self-reported daily cognitive abilities, while lower scores, defined as those falling below the population mean, reflect poorer self-reported daily cognitive abilities.
Baseline and Post Treatment (6 weeks)
Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test
Time Frame: Baseline and Post Treatment (6 weeks)
Change in scores on the Multiple Object Tracking task in the experimental group vs. controls This task measures sustained attention, cognitive control, and working memory, and requires participants to remember and track a set of target circles as they move around the screen, among a larger set of identical distractor circles. The outcome measure is the proportion of dots that a participant was able to track and identify successfully (on a scale of 0 to 1, with 0 being no dots and 1 being all of the dots). Higher proportion reflects better performance, while lower proportions reflect poorer task performance.
Baseline and Post Treatment (6 weeks)
Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test
Time Frame: Baseline and Post Treatment (6 weeks)
Change in scores on the Test My Brain (TMT) Digit Span Backwards task in the experimental group vs. controls. This task measures sustained attention and working memory. Participants are shown a series of numbers and asked to reproduce them in reverse order. Higher digit spans, defined as those exceeding the population mean (M = 5.98) reflect better performance, while lower digit spans reflect poorer task performance.
Baseline and Post Treatment (6 weeks)
Change in Cognitive Performance, as Measured by the Simple Reaction Time Test
Time Frame: Baseline and Post Treatment (6 weeks)
Change in scores on the Simple Reaction Time task in the experimental group vs. controls This task measures simple reaction time and psychomotor speed, and requires participants to press a key whenever a green square appears. Faster response times indicate better performance than slower response times.
Baseline and Post Treatment (6 weeks)
Change in Cognitive Performance, as Measured by the Choice Reaction Time Test
Time Frame: Baseline and Post Treatment (6 weeks)
Change in scores on the Choice Reaction Time task in the experimental group vs. controls This task measures processing speed and cognitive control, and requires participants to indicate the direction of an arrow that is a different color from the rest. Faster response times indicate better performance than slower response times.
Baseline and Post Treatment (6 weeks)
Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test
Time Frame: Baseline and Post Treatment (6 weeks)
This task measures sustained attention and set-shifting, and requires participants to switch between responses to letters and numbers. The outcome measure is proportion of correct switch trials, indicating that participants successfully switched from a letter response to a number response, or vice versa (on a scale of 0 to 1, with 0 being no correct switches and 1 being correct switches on all switch trials). Higher proportion correct for switch trials indicates better set-shifting performance, while lower proportion correct indicates worse set-shifting performance.
Baseline and Post Treatment (6 weeks)
Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test
Time Frame: Baseline and Post Treatment (6 weeks)
This task measures sustained attention and response inhibition, and requires participants to respond to target stimuli and ignore distractors. Performance is measured by d-prime, a measure of memory sensitivity and discrimination. D-prime is based on the calculation of hits (i.e., responding to a target when a target is present), misses (i.e., not responding when a target is present), false alarms (i.e., responding to a target when a distractor is present), and correct rejections (i.e., not responding when a distractor is present). D-prime scores range from 0 (chance) to 4.65 (based on hit rate of 0.99 and false alarm rate of 0.01). Greater d-prime scores reflect better performance than lower d-prime scores.
Baseline and Post Treatment (6 weeks)
Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task
Time Frame: Baseline and Post Treatment (6 weeks)
Change in scores on the Visual Paired Associates Task in the experimental group vs. controls. This task measures visual memory, and requires participants to learn and identify image pairs. The outcome measure is proportion of image pairs successfully recalled (on a scale of 0 to 1, with 0 being no image pairs and 1 being all of the image pairs). A higher proportion of correct image pairs reflects better performance than a lower proportion of correct image pairs.
Baseline and Post Treatment (6 weeks)
Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0
Time Frame: Baseline and Post Treatment (6 weeks)
Change in total score on the 36-item WHODAS in the experimental group vs. controls. The WHODAS 2.0 assesses the following domains of functioning: cognition, mobility, getting along, self-care, participation, and life activities. Scores range from 0 (no disability) to 100 (maximum disability), with higher scores reflecting a greater degree of overall functional disability.
Baseline and Post Treatment (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Akili Interactive Labs, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Faith Gunning, PhD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-11022977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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