The ACDC Study Assessing Cognitive Deterioration in COVID-19

NCT05855434 | Unknown DMC

• 1 other identifier: IRAS Project ID 314094
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term impact and effects of COVID-19 are still being determined. However, what is clear, is that some people are still struggling following a period of illness with COVID-19. Now known as 'long covid' or 'post covid-19 syndrome', people are not only experiencing physical symptoms like fatigue and breathlessness, but also psychological difficulties, as well as cognitive changes often referred to as 'brain fog'. This can include symptoms, such as changes in memory, difficulties with organisation and problem solving, as well as the ability to concentrate. Evidence from other research areas suggest that these changes could be due to shrinkage in areas of the brain that control functions like memory and concentration. There are also connections between different brain areas that work together to perform tasks such as remembering and concentrating, and these areas may also be affected by COVID-19. The purpose of this study is to scan the brains of patients reporting cognitive changes having been hospitalised with COVID-19 infection to see if any of these areas or connections have changed after infection and whether this might explain these cognitive changes.

Conditions

SARS-CoV-2 Infection; Cognitive Change; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint The primary endpoint is MR imaging and spectroscopy associations with measured cognitive performance.

  To report the association (present or not) between MR imaging and spectroscopy measures and cognitive performance following hospitalisation for COVID-19 disease.

  June 2024

Secondary Outcomes (3)

• Metabolic profile of selected brain regions via MRS

  June 2024

• White matter assessment via Tract Based Spatial Statistics (TBSS)

  June 2024

• Brain iron levels

  June 2024

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 16 and over who were hospitalised due to SARS-CoV-2 infection, having a positive PCR, and reporting cognitive change from baseline in the NHS Grampian region of Scotland.

You may qualify if:

• A patient who has been hospitalised with COVID-19 disease (with a positive Polymerase Chain Reaction (PCR) result for SARS-CoV2 infection) within NHS Grampian hospitals with subsequent subjective reporting and objective evidence of cognitive change.
• Patients aged over 18.
• Patient has completed neuropsychometric testing protocol as described above.
• Participant who is willing and able to give informed consent for participation in the study.

You may not qualify if:

• Any patient whose physical condition will preclude them from lying still for the duration of the brain scan.
• Contraindication to magnetic resonance scanning such as an implantable cardiac device.
• Patients who required intensive care treatment for SARS-CoV2 infection.
• Patients with a pre-existing diagnosis of a Neurodegenerative disease (eg. Dementia), Intellectual Disability, previous moderate/severe brain injury or previous brain injury with noted cognitive change.
• Patients with a pre-existing neuro-inflammatory disorder (eg. Multiple Sclerosis).
• Patients under investigation for, or with a history of, cognitive change prior to hospitalisation with COVID-19 disease.
• Patients with a dependency on alcohol or recreational drugs.

Sponsors & Collaborators

• NHS Grampian: lead
• University of Aberdeen: collaborator

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Grampian, AB25 2ZH, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction

Interventions

Magnetic Resonance Imaging

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)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Jonathan McLaughlin, MBChB BA MSc

CONTACT

01224552094; jonathan.mclaughlin@nhs.scot

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 11, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)