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Behavioural Intervention

AKL-T01 for Coronavirus

Phase 2
Waitlist Available
Led By Faith Gunning, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post treatment (6 weeks)
Awards & highlights

Study Summary

This trial is testing a digital cognitive intervention to see if it can improve cognitive functioning in people who have had COVID-19.

Eligible Conditions
  • Coronavirus
  • Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post treatment (6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post treatment (6 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task
Secondary outcome measures
Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test
Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test
Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AKL-T01 InterventionExperimental Treatment1 Intervention
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.
Group II: Waitlist ControlActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AKL-T01
2018
Completed Phase 2
~860

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,762 Total Patients Enrolled
Akili Interactive Labs, Inc.Industry Sponsor
15 Previous Clinical Trials
5,055 Total Patients Enrolled
Faith Gunning, PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any know side effects of AKL-T01?

"Given that this is a phase 2 trial and there is only data supporting safety and no efficacy, our team has given AKL-T01 a score of 2."

Answered by AI

Which patients would be an ideal fit for this particular clinical trial?

"This trial is looking for 125 participants who have cognitive decline and are between 18 and 89 years old. In addition to this, potential patients must meet the following criteria: a 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, being male or female, documentation of a deficit in cognitive function compared to age-adjusted normative data on at least one screening measure of attention and executive function, ability to connect wireless devices to a functional wireless"

Answered by AI

Are there any vacancies in this trial for volunteers?

"Yes, this trial is still recruiting patients according to the latest update on clinicaltrials.gov. The listing was first posted almost a year ago on June 17th, 2021 and was updated less than two weeks ago on June 29th, 2022."

Answered by AI

Is this study's target age group older adults?

"Eligible participants for this clinical trial must be over 18 and under 89 years of age."

Answered by AI

How many willing participants are there for this experiment?

"That is correct, the online clinicaltrials.gov registry indicates that this study is currently recruiting patients. The trial was first posted on June 17th, 2021 and has been updated as recently as June 29th, 2022. They are looking for a total of 125 participants at 1 location."

Answered by AI
~30 spots leftby Mar 2025