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NCT06029335 Clinical Trial

Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Healthy Clinical Trial

Official title:
Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06029335
Other study ID # 35147-3/2020/ EÜIG
Secondary ID 05570-6/2023
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date August 30, 2023

Study information
Verified date September 2023
Source University of Pecs
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date August 30, 2023
Est. primary completion date October 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Systemic autoimmune diseases - Healthy individuals - as controls Exclusion Criteria: - Diseases of the central nervous system - Presence of pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Hungary University of Pécs, Department of Rheumatology and Immunology Pécs

Sponsors (1)
Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mini-mental State Examination Complex Cognitive measure 12 months
Primary The Functional Assessment of Chronic Illness Therapy F health-related quality of life measure 12 months
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