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临床试验/NCT06029335
NCT06029335进行中(未招募)不适用

Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

University of Pecs1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
1
主要终点
Mini-mental State Examination

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemic autoimmune diseases
  • Healthy individuals - as controls

排除标准

  • Diseases of the central nervous system
  • Presence of pregnancy

结局指标

主要结局

Mini-mental State Examination

时间窗: 12 months

Complex Cognitive measure

The Functional Assessment of Chronic Illness Therapy F

时间窗: 12 months

health-related quality of life measure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr Varjú Cecília

Associate Professor

University of Pecs

研究点 (1)

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