Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

NCT ID: NCT06029335

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-08-30

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.

Detailed Description

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Conditions

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Systemic Sclerosis Systemic Lupus Erythematosus Myopathies, Inflammatory Rheumatoid Arthritis Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Healthy

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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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dr Varjú Cecília

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pécs, Department of Rheumatology and Immunology

Pécs, , Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type BACKGROUND
PMID: 32293528 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40757427 (View on PubMed)

Other Identifiers

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05570-6/2023

Identifier Type: OTHER

Identifier Source: secondary_id

35147-3/2020/ EÜIG

Identifier Type: -

Identifier Source: org_study_id

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