Phase 2
N=110
Improving Cognitive Health in COVID-19 Survivors
Cognitive Dysfunction · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04843930 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task — 63.0; 63.5; 67.8; 69.0 number of correct matches — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AKL-T01 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task |
63.0; 63.5; 67.8; 69.0 | 0.54 |
| SECONDARY Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale |
25.4; 25.7; 30.2; 28.6 | 0.04 sig |
| SECONDARY Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test |
0.72; 0.73; 0.78; 0.76 | 0.79 |
| SECONDARY Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test |
4.7; 4.9; 5.6; 5.7 | 0.45 |
| SECONDARY Change in Cognitive Performance, as Measured by the Simple Reaction Time Test |
450; 434; 375; 411 | 0.02 sig |
| SECONDARY Change in Cognitive Performance, as Measured by the Choice Reaction Time Test |
1183; 1164; 1062; 1028 | 0.96 |
| SECONDARY Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test |
0.93; 0.95; 0.98; 0.96 | 0.04 sig |
| SECONDARY Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test |
2.3; 2.3; 2.4; 2.4 | 0.60 |
| SECONDARY Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task |
0.56; 0.56; 0.60; 0.67 | 0.06 |
| SECONDARY Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0 |
70.4; 69.8; 60.4; 66.1 | 0.04 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04843930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.