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

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.

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico Carlo Besta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Italian speakers, already followed at Besta Institute

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GEMS	Global examination of cognitive functioning	22 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRIq	Cognitive reserve index	22 months
ENB-3	Brief Neuropsychological battery	22 months
MG-DIS	Disability	22 months
MG-QOL15	Quality of life	22 months
MG-ADL	Activities of Daily Living	22 months
WPAI-GH	Impact on work-related activities and productivity	22 months
HADS	Anxiety and depression	22 months
FSS	Fatigue Severity	22 months
CCI	Presence of comorbidities	22 months
Clinical profile	General information on MG type, antibody profile, sociodemographic information, MG-specific symptoms, pharmacological therapy	22 months

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): August 12, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Anxiety; Myasthenia Gravis; Attention; Memory; Activities of Daily Living; Disability; Executive Functions; Cognitive Reserve; Comorbidities; Cognitive Functioning; Work
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Behavior; Anxiety Disorders; Depression; Myasthenia Gravis
• Other Study ID Numbers: MYCOG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No