Clinical trial NCT04843930: Improving Cognitive Health in COVID-19 Survivors
Official title: Improving Cognitive Health in COVID-19 Survivors Through Digital Therapeutics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Dysfunction
Covid19
Keywords: Covid19
Cognitive Dysfunction
Attention Disturbances
Cognitive Change
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Akili Interactive Labs, Inc.
First posted: 2021-04-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task
timeFrame: Baseline and Post Treatment (6 weeks)
Secondary outcomes:
measure: Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Cognitive Performance, as Measured by the Simple Reaction Time Test
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Cognitive Performance, as Measured by the Choice Reaction Time Test
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0
timeFrame: Baseline and Post Treatment (6 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Faith Gunning, PhD
role: PRINCIPAL_INVESTIGATOR
References: