Improving Cognitive Health in COVID-19 Survivors

NCT04843930 | Completed Phase 2 Results FDA Device

• 1 other identifier: 20-11022977
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Covid19

Keywords

Covid19; Cognitive Dysfunction; Attention Disturbances; Cognitive Change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale

  Baseline and Post Treatment (6 weeks)

• Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test

  Baseline and Post Treatment (6 weeks)

• Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test

  Baseline and Post Treatment (6 weeks)

• Change in Cognitive Performance, as Measured by the Simple Reaction Time Test

  Baseline and Post Treatment (6 weeks)

• Change in Cognitive Performance, as Measured by the Choice Reaction Time Test

  Baseline and Post Treatment (6 weeks)

Study Arms (2)

AKL-T01 Intervention

EXPERIMENTAL

Participants in the experimental group will complete 6 weeks of the AKL-T01 intervention. Participants enrolled in the intervention arm will play the game via an iPad application for 20-25 minutes daily for at least 5 days a week (but up to 7 days a week). Participants will also have weekly check-in visits via phone or a secure HIPAA compliant videoconferencing platform (Zoom) with a care manager, who will monitor mood symptoms and gameplay adherence.

Device: AKL-T01

Waitlist Control

NO INTERVENTION

Participants in the Waitlist Control arm will not be engaging in any active control condition. Participants in the waitlist control arm will continue any ongoing self- or provider-based cognitive intervention (or no intervention) during the initial 6-week waitlist period. Participants will also have weekly check-in visits via phone or a secure HIPAA compliant videoconferencing platform (Zoom) with a care manager, who will monitor mood symptoms. The control arm will be offered the intervention at the end of 6 weeks waitlist period to ensure all participants ultimately have access to the intervention.

Interventions

AKL-T01 DEVICE

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.

AKL-T01 Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Akili Interactive Labs, Inc.: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; COVID-19

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Lindsay Victoria, PhD
• Organization: Weill Cornell Medicine

liv3002@med.cornell.edu

646-962-3973

Study Officials

• Faith Gunning, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and care managers will be instructed not to reveal the group assignment to the member of the research team conducting assessments. Following the completion of recruitment, data analysts will be provided with the data for the arms simply labelled as "Group A" and "Group B" to avoid bias. These generic labels will be unmasked only after completion of all the planned statistical analyses described below. Participants in the waitlist control arm who begin the intervention at the end of the waitlist period will have different assessors for the initial 6-week control procedures and the subsequent 6-week intervention period so as to maintain the blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 14, 2021
• Study Start: July 13, 2021
• Primary Completion: February 6, 2023
• Study Completion: April 26, 2023
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)