Status:
COMPLETED
Improving Cognitive Health in COVID-19 Survivors
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Akili Interactive Labs, Inc.
Conditions:
Cognitive Dysfunction
Covid19
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
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...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04843930
Start Date
July 13 2021
End Date
April 26 2023
Last Update
February 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Cornell Medicine
New York, New York, United States, 10065