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Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Sponsor
University of Pecs (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06029335
Collaborator
(none)
400
Enrollment
1
Location
35.9
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases
    Actual Study Start Date :
    Sep 1, 2020
    Actual Primary Completion Date :
    Oct 10, 2022
    Anticipated Study Completion Date :
    Aug 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Mini-mental State Examination [12 months]

      Complex Cognitive measure

    2. The Functional Assessment of Chronic Illness Therapy F [12 months]

      health-related quality of life measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Systemic autoimmune diseases

    • Healthy individuals - as controls

    Exclusion Criteria:

    • Diseases of the central nervous system

    • Presence of pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pécs, Department of Rheumatology and Immunology Pécs Hungary 7632

    Sponsors and Collaborators

    • University of Pecs

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    dr Varjú Cecília, Associate Professor, University of Pecs
    ClinicalTrials.gov Identifier:
    NCT06029335
    Other Study ID Numbers:
    • 35147-3/2020/ EÜIG
    • 05570-6/2023
    First Posted:
    Sep 8, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myositis
    Lupus Erythematosus, Systemic
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Autoimmune Diseases

    Study Results

    No Results Posted as of Sep 11, 2023