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Kognitiv trening hos overlevende etter Covid-19: En randomisert prøvelse

29. september 2026 oppdatert av: James C. Jackson, Vanderbilt University Medical Center

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).

Studieoversikt

Status

Fullført

Detaljert beskrivelse

As the Investigators have described, a frequent and particularly disabling consequence of Covid-19 may be in the cognitive arena, with deleterious implications for employment, quality of life, and other dimensions of functioning. As such, efforts to develop interventions aimed at improving neuropsychological outcomes are important and a key feature of an overarching public health strategy. One potential intervention of interest is cognitive training, which has been employed with increasing success with wide-ranging populations, though only minimally with survivors of critical illness and not with Covid-19 patients at all. Cognitive training, particularly the kind that relies on what are known as digital interventions (programs which, functionally, look like video games) is particularly appropriate in the pandemic climate, as it can be done entirely in a virtual contactless fashion, thus decreasing the risk of infection. The Investigators propose a pilot study in 100 cognitively impaired community dwelling patients who tested positive for Covid-19 and are participants in an existing study/ongoing study of household transmission of Covid-19 (the SARS-Co-V-2 Household Transmission Study, with the following specific aim and hypotheses:

Study Aim: 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.

Hypothesis 1: A trial evaluating AKL-T01 for improving long-term cognition in community dwelling and cognitively abnormal COVID-19 patients will be feasible, as denoted by achieving each of the following in this pilot trial: (a) recruitment and successful protocol completion of up to 100 patients; (b) successful completion of 4-week cognitive assessments by >80% of survivors; and (c) the primary cognitive outcome (a composite score on CNS Vital Signs) numerically favoring the intervention group with the one-tailed upper 80% confidence interval of the difference in a composite outcome between the intervention and placebo groups containing the minimally-important clinical difference on a CNS Vital Signs composite measure.

Studietype

Intervensjonell

Registrering (Faktiske)

83

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Vanderbilt University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years
  2. Laboratory-confirmed SARS-CoV-2 infection prior to randomization (we will track the specific date at which Covid-19 was diagnosed)
  3. 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.

Exclusion Criteria:

  1. Non-English speaking
  2. Incarcerated
  3. Blind/ color blind
  4. Unable to play the game due to a physical disability
  5. Unable to play the game due to severe cognitive impairment (e.g., too inattentive or delirious) prior to randomization.
  6. 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.
  7. Previously enrolled in a study using AKL-T01
  8. 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.
  9. 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

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.

Placebo komparator: Placebo

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improve cognition
Tidsramme: 4 weeks

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. august 2021

Primær fullføring (Faktiske)

31. juli 2024

Studiet fullført (Faktiske)

31. desember 2024

Datoer for studieregistrering

Først innsendt

7. juli 2021

Først innsendt som oppfylte QC-kriteriene

7. juli 2021

Først lagt ut (Faktiske)

9. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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