Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
NCT Number: NCT06718855
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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Notify Me18 year–99 year
All sexes
Observational
Milan, 20133, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 22 months
Global examination of cognitive functioning
Time frame: 22 months
Cognitive reserve index
Time frame: 22 months
Brief Neuropsychological battery
Time frame: 22 months
Disability
Time frame: 22 months
Quality of life
Time frame: 22 months
Activities of Daily Living
Time frame: 22 months
Impact on work-related activities and productivity
Time frame: 22 months
Anxiety and depression
Time frame: 22 months
Fatigue Severity
Time frame: 22 months
Presence of comorbidities
Time frame: 22 months
General information on MG type, antibody profile, sociodemographic information, MG-specific symptoms, pharmacological therapy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Other
Acronym: MYCOG
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