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临床试验/NCT06718855
NCT06718855已完成不适用

Cognitive Functioning in People With Myasthenia Graivs: Impact on Daily Life Activities, Work, Disability and Quality of Life

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
GEMS

研究概览

简要总结

MYCOG primarily aims to estimate the prevalence of cognitive difficulties in patients with MG treated at Besta Institute. Secondary aims include: a) assess the degree to which cognitive difficulties are associated to work impairment, limitations in ADL, symptoms of anxiety and depression, fatigue, disability and QoL; b) assess whether patients with different MG types show different degrees of cognitive impairment; c) assess whether patients with different MG antibody profiles show different degrees of cognitive impairment; d) assess whether patients under different MG-specific pharmacological treatments show different degrees of cognitive impairment.

详细描述

Previous literature findings provide contradictory indications about presence of cognitive impairment in patients with MG, but patients experience different degree of limitations in ADLs, disability and QoL which might not be entirely understood on the basis of neuromuscular symptoms. We therefore aimed to address the potential impact of cognitive impairment.

MYCOG is a monocentric, cross-sectional and observational study which primarily aims to estimate the prevalence of cognitive difficulties, measured with Global Examination of Mental State (GEMS), in patients with MG treated at Besta Institute. Secondary aims include: a) assess the degree to which cognitive difficulties are associated to work impairment (measured with WPAI-GH), limitations in ADL (measured with MG-ADL), symptoms of anxiety and depression (measured with HADS), fatigue (measured with FSS), disability and QoL (measured with MG-DIS and MG-QOL15); b) assess whether patients with different MG types (ocular, generalized, bulbar, pharmacological remission and clinical stable remission) show different degrees of cognitive impairment; c) assess whether patients with different MG antibody profiles (AChR, MuSK, Double Negative) show different degrees of cognitive impairment; d) assess whether patients under different MG-specific pharmacological treatments (piridogstigmine, steroids, other therapies such as immunemodulators) show different degrees of cognitive impairment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with MG,
  • followed-up at Besta institute
  • aged 18-99,
  • able to understand Italian language;

排除标准

  • psychiatric comorbidies of psychotic nature;
  • do not accept to participate on a voluntary basis;
  • patients who should be excluded based on physician's judgement;
  • patients who live in a nursing home for aged or disabled persons;
  • respiratory impairment (patients under mechanical ventilation)

结局指标

主要结局

GEMS

时间窗: 22 months

Global examination of cognitive functioning

次要结局

  • CRIq(22 months)
  • ENB-3(22 months)
  • MG-DIS(22 months)
  • MG-QOL15(22 months)
  • MG-ADL(22 months)
  • WPAI-GH(22 months)
  • HADS(22 months)
  • FSS(22 months)
  • CCI(22 months)
  • Clinical profile(22 months)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Sponsor

研究点 (1)

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