Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Systemic Sclerosis; Myopathies, Inflammatory

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Hungary
  • Pécs, Hungary, 7632
    • University of Pécs, Department of Rheumatology and Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• Systemic autoimmune diseases
• Healthy individuals - as controls

Exclusion Criteria:

• Diseases of the central nervous system
• Presence of pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pecs

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): October 10, 2022
• Study Completion (Estimated): August 30, 2023

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Immune System Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Scleroderma, Diffuse; Myositis; Autoimmune Diseases
• Other Study ID Numbers: 35147-3/2020/ EÜIG; 05570-6/2023 (Other Identifier: National Public Health Centre Institutional Committee of Science and Research Ethics Hungary)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are not publicly available due to ethical issues.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No