For COVID-19 vaccine updates, please review our information guide. For patient eligibility and scheduling availability, please visit VaccineTogetherNY.org.

Improving Cognitive Health in COVID-19 Survivors Through Digital Therapeutics

Clinical Trial Details

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.   

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.

Key Eligibility: 

Inclusion Criteria: 

  • Male or female 18-89 years of age
  • Documentation of a deficit in cognitive function on at least one screening measure of attention and executive function
  • Previous diagnosis of COVID-19 confirmed via SARS-CoV-2 polymerase chain reaction (PCR) test 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 primary investigator 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

 

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Lauren Oberlin
(646) 289-5204 ext. 707
leo4001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2011022977

Status

Not Yet Recruiting

Age Group

Adult

Sponsor