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Clinical Trials/NCT06029335
NCT06029335
Active, Not Recruiting
N/A

Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

University of Pecs1 site in 1 country400 target enrollmentSeptember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Systemic Sclerosis
Sponsor
University of Pecs
Enrollment
400
Locations
1
Primary Endpoint
Mini-mental State Examination
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases.

Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
August 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr Varjú Cecília

Associate Professor

University of Pecs

Eligibility Criteria

Inclusion Criteria

  • Systemic autoimmune diseases
  • Healthy individuals - as controls

Exclusion Criteria

  • Diseases of the central nervous system
  • Presence of pregnancy

Outcomes

Primary Outcomes

Mini-mental State Examination

Time Frame: 12 months

Complex Cognitive measure

The Functional Assessment of Chronic Illness Therapy F

Time Frame: 12 months

health-related quality of life measure

Study Sites (1)

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