Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

NCT06029335 | Unknown

• 2 other identifiers: 35147-3/2020/ EÜIG05570-6/2023
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (7)

Diffuse cutaneous Systemic sclerosis

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

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

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

Healthy

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients were enrolled into the study originating from the Rheumatology and Immunology Department, Medical School, University of Pécs. Control healthy groups including consecutive sex and age-matched healthy individuals are invited to participate.

You may qualify if:

• Systemic autoimmune diseases
• Healthy individuals - as controls

You may not qualify if:

• Diseases of the central nervous system
• Presence of pregnancy

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

University of Pécs, Department of Rheumatology and Immunology

Pécs, 7632, Hungary

Location

Related Publications (2)

• Olah C, Schwartz N, Denton C, Kardos Z, Putterman C, Szekanecz Z. Cognitive dysfunction in autoimmune rheumatic diseases. Arthritis Res Ther. 2020 Apr 15;22(1):78. doi: 10.1186/s13075-020-02180-5.

  PMID: 32293528 BACKGROUND

• Krampek L, Kiss F, Farkas N, Faludi R, Nagy G, Szabo A, Czirjak L, Varju C. Risk factors of cognitive function impairment in patients with systemic sclerosis. Clin Exp Rheumatol. 2025 Aug;43(8):1481-1491. doi: 10.55563/clinexprheumatol/isx6h8. Epub 2025 Aug 1.

  PMID: 40757427 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Investigations of serum samples for biomarkers

MeSH Terms

Conditions

Scleroderma, Systemic; Lupus Erythematosus, Systemic; Myositis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: September 1, 2020
• Primary Completion: October 10, 2022
• Study Completion: August 30, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)