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OpenTrials
Completed

NCT Number: NCT06718855

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. GEMS

    Time frame: 22 months

    Global examination of cognitive functioning

Secondary outcomes

  1. CRIq

    Time frame: 22 months

    Cognitive reserve index

  2. ENB-3

    Time frame: 22 months

    Brief Neuropsychological battery

  3. MG-DIS

    Time frame: 22 months

    Disability

  4. MG-QOL15

    Time frame: 22 months

    Quality of life

  5. MG-ADL

    Time frame: 22 months

    Activities of Daily Living

  6. WPAI-GH

    Time frame: 22 months

    Impact on work-related activities and productivity

  7. HADS

    Time frame: 22 months

    Anxiety and depression

  8. FSS

    Time frame: 22 months

    Fatigue Severity

  9. CCI

    Time frame: 22 months

    Presence of comorbidities

  10. Clinical profile

    Time frame: 22 months

    General information on MG type, antibody profile, sociodemographic information, MG-specific symptoms, pharmacological therapy

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Registry information

Acronym: MYCOG

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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