Cognitive Training in Survivors of Covid-19: A Randomized Trial

NCT04956887 | Completed

• 1 other identifier: 210121
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Preliminary evidence suggests that cognitive impairment is a common outcome experienced by individuals surviving Covid-19 (1-5). Cognitive impairment following Covid-19 which leads to critical illness is not surprising and perhaps even expected. However, significant cognitive deficits appear to be common even among individuals testing positive for Covid-19 who were never hospitalized. Questions exist regarding the mechanisms of the aforementioned cognitive impairment. The association between COVID-19 and brain dysfunction is not surprising since SARS-CoV has been found in the brain and because Coronaviridaes (CoVs) have been associated with central nervous system (CNS) diseases such as acute viral encephalopathy, acute disseminated encephalomyelitis, and multiple sclerosis (6-11).The possible brain entry routes for CoVs include either direct intranasal access to the brain via olfactory nerves or indirect access by crossing the blood-brain barrier (BBB) via hematogenous or lymphatic spread (9).

Conditions

Covid19; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Improve cognition

  To evaluate the feasibility of conducting a randomized trial evaluating the effectiveness of a digital app-based intervention (AKL-T01) to improve 4-week cognition (post-intervention) in cognitively impaired survivors of Covid-19.

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: AKL-T01

Placebo

PLACEBO COMPARATOR

Patients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning.

Other: Control Group

Interventions

AKL-T01 BEHAVIORAL

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.

Intervention

Control Group OTHER

Patients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning

Placebo

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Laboratory-confirmed SARS-CoV-2 infection prior to randomization (we will track the specific date at which Covid-19 was diagnosed)
• Presence of objective cognitive impairment (less than 18 on the MOCA-Blind) and/or the presence of subjective cognitive decline via the IQCODE-Short Form, as reflected in a score greater than 3.3.

You may not qualify if:

• Non-English speaking
• Incarcerated
• Blind/ color blind
• Unable to play the game due to a physical disability
• Unable to play the game due to severe cognitive impairment (e.g., too inattentive or delirious) prior to randomization.
• A known cognitive condition such as progressive dementia that would likely prevent the participant from responding to the effects of cognitive training or prevent them from being able to engage in self-consent.
• Previously enrolled in a study using AKL-T01
• Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
• Any other clinical condition that would jeopardize patient's safety while participating in this trial or may prevent the patient from adhering to the trial protocol.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor of Medicine

Model Details: After the patient or authorized surrogate provides informed consent, the cognitive training and rehabilitation intervention versus usual care will be randomly assigned at a 1:1 allocation ratio. Computerized randomization will occur after informed consent has been obtained using a permuted-block randomization scheme with varying block size. We will use adequate allocation concealment using a computer-generated, permuted-block randomization scheme with varying block size. The block size and randomization list will only be known to the independent biostatistician creating the randomization list and will not be shared with trial investigators or any other study personnel, as this information could make it easier to correctly guess the next treatment allocation. This list will be directly uploaded into REDCap's randomization module.16

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 9, 2021
• Study Start: August 3, 2021
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

US (1)