Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

University of Pecs

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT06029335

05570-6/2023 (Other Identifier)

35147-3/2020/ EÜIG

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemic autoimmune diseases
• Healthy individuals - as controls

Exclusion criteria

• Diseases of the central nervous system
• Presence of pregnancy

Trial design

400 participants in 7 patient groups

Diffuse cutaneous Systemic sclerosis

Description:

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

Description:

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

Description:

Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.

Healthy

Description:

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

Description:

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

Description:

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

Description:

Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.