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Improving Cognitive Health in COVID-19 Survivors

Primary Purpose

Cognitive Dysfunction, Covid19

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AKL-T01

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring Covid19, Cognitive Dysfunction, Attention Disturbances, Cognitive Change

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AKL-T01 Intervention

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in cognitive function, as measured by the Digit Symbol Matching Task

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 (mean = 65.79) reflect better task performance and scores below the normative mean reflect poorer performance.

Secondary Outcome Measures

Change in daily functioning, as measured by the NeuroQOL Cognitive Function scale

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 normative mean (mean (SD) = 50.09 (10.23)), reflect better self-reported daily cognitive abilities, while lower scores, defined as those falling below the t-score mean of the normative sample, reflect poorer self-reported daily cognitive abilities.

Change in cognitive performance, as measured by the Multiple Object Tracking test

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 primary outcome measure is the number of dots that a participant was able to track and identify successfully. Higher scores, defined as those exceeding the normative mean (M = 56.94) reflect better performance, while lower scores reflect poorer task performance.

Change in cognitive performance, as measured by the Digit Span Backwards test

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 scores, defined as those exceeding the normative mean (M = 5.98) reflect better performance, while lower scores reflect poorer task performance.

Change in cognitive performance, as measured by the Simple Reaction Time test

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. Higher scores, defined as those exceeding the normative mean (M = 31.71) reflect faster response times, while lower scores reflect slower response times.

Change in cognitive performance, as measured by the Choice Reaction Time test

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. Higher scores, defined as those exceeding the normative mean (M = 11.49) reflect better performance, while lower scores reflect poorer performance.

Change in cognitive performance, as measured by the Letter-Number Switching test

Change in scores on the Letter-Number Switching task in the experimental group vs. controls This task measures sustained attention and set-shifting, and requires participants to switch between responses to letters and numbers. Lower scores, defined as those below the normative mean (M = 1.06) reflect better set-shifting performance, while higher scores reflect poorer set-shifting performance.

Change in cognitive performance, as measured by the Gradual Onset Continuous Performance Test

Change in scores on the Gradual Onset Continuous Performance Test in the experimental group vs. controls This task measures sustained attention and response inhibition, and requires participants to respond to specific stimuli and ignore distractors.. Higher scores, defined as those exceeding the normative mean (M = 67.97) reflect better performance, while lower scores reflect poorer performance.

Change in cognitive performance, as measured by the Visual Paired Associates Task

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 iamge pairs. Higher scores, defined as those exceeding the normative mean (M = 10.53) reflect better performance, while lower scores reflect poorer performance.

Change in overall daily functioning, as measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0

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.

Full Information

NCT ID

NCT04843930

First Posted

April 10, 2021

Last Updated

May 8, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

Akili Interactive Labs, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04843930

Brief Title

Improving Cognitive Health in COVID-19 Survivors

Official Title

Improving Cognitive Health in COVID-19 Survivors Through Digital Therapeutics

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

June 17, 2021 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Akili Interactive Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Dysfunction, Covid19

Keywords

Covid19, Cognitive Dysfunction, Attention Disturbances, Cognitive Change

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This study is a randomized clinical trial designed to compare efficacy of the AKL-T01 intervention relative to a waitlist control in patients who were infected with COVID-19. Participants will be randomized to the AKL-T01 or a waitlist control. We will use a waitlist design; at the end of the intervention period, participants in the control group will have the option to receive the 6-week AKL-T01 intervention.

Masking

InvestigatorOutcomes Assessor

Masking Description

Participants and care managers will be instructed not to reveal the group assignment to the member of the research team conducting assessments. Following the completion of recruitment, data analysts will be provided with the data for the arms simply labelled as "Group A" and "Group B" to avoid bias. These generic labels will be unmasked only after completion of all the planned statistical analyses described below. Participants in the waitlist control arm who begin the intervention at the end of the waitlist period will have different assessors for the initial 6-week control procedures and the subsequent 6-week intervention period so as to maintain the blind.

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AKL-T01 Intervention

Arm Type

Experimental

Arm Description

Arm Title

Waitlist Control

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

AKL-T01

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in cognitive function, as measured by the Digit Symbol Matching Task

Description

Time Frame