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

NCT ID: NCT06718855

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-07

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Myasthenia Gravis

Keywords

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Myasthenia Gravis Cognitive Functioning Disability Activities of Daily Living Quality of Life Anxiety Comorbidities Work Depression Memory Attention Executive Functions Cognitive Reserve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessia Marcassoli, MS

Role: CONTACT

Phone: +39 02 2394

Email: [email protected]

Alberto Raggi, PhD

Role: CONTACT

Phone: +39 2394

Email: [email protected]

Facility Contacts

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Alessia Marcassoli, MS

Role: primary

Alberto Raggi, PhD

Role: backup

Alessia Marcassoli, MS

Role: backup

Alberto Raggi, PhD

Role: backup

Other Identifiers

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MYCOG

Identifier Type: -

Identifier Source: org_study_id