Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Active, not recruiting

• Conditions: Myopathies, Inflammatory; Systemic Sclerosis; Systemic Lupus Erythematosus; Rheumatoid Arthritis; Healthy

• Registration Number: NCT06029335
• Lead Sponsor: University of Pecs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2022-10-10
• Study Completion: 2023-08-30
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Systemic autoimmune diseases
• Healthy individuals - as controls

Exclusion Criteria

• Diseases of the central nervous system
• Presence of pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mini-mental State Examination	12 months	Complex Cognitive measure
The Functional Assessment of Chronic Illness Therapy F	12 months	health-related quality of life measure

Trial Locations

Locations (1)

University of Pécs, Department of Rheumatology and Immunology; 🇭🇺 Pécs, Hungary