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PrimeCog: Primary Care Cognitive Testing

NCT06346535 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-04-23

No results posted yet for this study

Summary

The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD/SED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated.

Conditions

  • Mental Health Issue
  • Cognitive Symptom
  • Primary Health Care

Interventions

DIAGNOSTIC_TEST

Cognitive Testing

Digital Cognitive Testing performed at home.

Sponsors & Collaborators

  • Region Östergötland

    lead OTHER

Principal Investigators

  • Hanna Israelsson Larsen, PhD · Region Ostergotland/Linkoping University

  • Anna Segernas, PhD · Region Ostergotland/Linkoping University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-04-01
Completion
2029-04-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06346535 on ClinicalTrials.gov