Improving Cognitive Health in COVID-19 Survivors

Covid19 Clinical Trial

Official title:

Improving Cognitive Health in COVID-19 Survivors Through Digital Therapeutics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843930
• Other study ID #: 20-11022977
• Status: Completed
• Phase: Phase 2
• Start date: July 13, 2021
• Est. completion date: April 26, 2023

Study information

• Verified date: February 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 26, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Akili Interactive Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Function, as Measured by Number Correct on 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 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	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 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)
Secondary	Change in Cognitive Performance, as Measured by Proportion Correct on 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 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)
Secondary	Change in Cognitive Performance, as Measured by Digit Span on 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 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)
Secondary	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. Faster response times indicate better performance than slower response times.	Baseline and Post Treatment (6 weeks)
Secondary	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. Faster response times indicate better performance than slower response times.	Baseline and Post Treatment (6 weeks)
Secondary	Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test	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)
Secondary	Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test	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)
Secondary	Change in Cognitive Performance, as Measured by Percent Correct on 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 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)
Secondary	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.	Baseline and Post Treatment (6 weeks)