Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Conditions
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Systemic Sclerosis, Systemic Lupus Erythematosus, Myopathies, Inflammatory, Rheumatoid Arthritis, Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemic autoimmune diseases Healthy individuals - as controls Exclusion Criteria: Diseases of the central nervous system Presence of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diffuse cutaneous Systemic sclerosis<br>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Limited cutaneous Systemic sclerosis<br>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Primary Raynaud's<br>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Healthy<br>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Rheumatoid arthritis<br>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Inflammatory myopathies<br>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Systemic lupus erythematosus<br>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-mental State Examination | Complex Cognitive measure | 12 months | 
| The Functional Assessment of Chronic Illness Therapy F | health-related quality of life measure | 12 months |