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

Recruiting

• Conditions: Myasthenia Gravis

• Registration Number: NCT06718855
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Brief Summary

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.

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 Timeline

• Study Start: 2023-06-07
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GEMS	22 months	Global examination of cognitive functioning

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta; 🇮🇹 Milano, Italy