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Behavioural Intervention
Cognitive Training for Post-COVID-19 Cognitive Impairment
N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial suggests that cognitive impairment is a common outcome for people who have had Covid-19, even if they were never hospitalized. It's not clear how Covid-19 causes cognitive impairment, but it's possible that the virus enters the brain directly or indirectly.
Who is the study for?
This trial is for adults over 18 who've had COVID-19 and are now experiencing cognitive issues, confirmed by specific tests. It's not for those with pre-existing conditions like progressive dementia, non-English speakers, or individuals with severe impairments that prevent game interaction.Check my eligibility
What is being tested?
The study is testing AKL-T01, a cognitive training program against a control group to see if it helps improve brain function in people who have had COVID-19 and are facing mental challenges.See study design
What are the potential side effects?
Since the intervention involves cognitive training exercises, traditional physical side effects are unlikely. However, participants may experience frustration or fatigue from the mental tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improve cognition
Side effects data
From 2023 Phase 2 trial • 110 Patients • NCT048439304%
Dizziness
2%
Headache
2%
Planned surgery
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
AKL-T01 Intervention
Waitlist Control
Control Arm Participants Who Started AKL-T01 Intervention
Control Arm Participants Who Declined AKL-T01 Intervention
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
The study intervention, AKL-T01 (Akili Interactive), is a digital, app-based intervention designed to target and improve cognition through an engaging video game-based software experience delivered on an iPad.
Group II: PlaceboPlacebo Group1 Intervention
Patients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning.
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?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,092 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot play the game because of my physical disability.I do not have a cognitive condition that prevents me from understanding or consenting to treatment.I am 18 years old or older.You have tested positive for COVID-19 before the start of the study.I do not speak English.You are currently in prison.I cannot focus or think clearly enough to play games.You have a noticeable problem with memory and thinking, as measured by specific tests.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are recruited for this experiment?
"Affirmative. The research was posted on August 3rd 2021 and the latest update to its details occurred on March 4th 2022, as per clinicaltrials.gov, indicating that recruitment is in progress. This study requires a hundred volunteers from one medical centre."
Answered by AI
Is the recruitment process for this trial still open to new participants?
"Affirmative. The clinicaltrials.gov webpage confirms that the study, published on August 3rd 2021, is presently recruiting volunteers. One hundred participants are required at a single trial site."
Answered by AI
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