Myasthenia GravisMYCOGNCT06718855
Cognitive Functioning in People With Myasthenia Graivs: Impact on Daily Life Activities, Work, Disability and Quality of Life
An observational study of Myasthenia Gravis, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jun 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Italian speakers, already followed at Besta Institute
Who may be able to join
- Patients with MG,
- followed-up at Besta institute
- aged 18-99,
- able to understand Italian language;
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Cognitive Functioning, Disability, Activities of Daily Living, Quality of Life, Anxiety, Comorbidities, Work, Depression, Memory, Attention, Executive Functions, Cognitive Reserve
- Medical subject headings
- Myasthenia Gravis, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
GEMS
Global examination of cognitive functioning
Measured: 22 months
Secondary outcomes (10)
CRIq
Cognitive reserve index
Measured: 22 months
ENB-3
Brief Neuropsychological battery
Measured: 22 months
MG-DIS
Disability
Measured: 22 months
MG-QOL15
Quality of life
Measured: 22 months
MG-ADL
Activities of Daily Living
Measured: 22 months
WPAI-GH
Impact on work-related activities and productivity
Measured: 22 months
HADS
Anxiety and depression
Measured: 22 months
FSS
Fatigue Severity
Measured: 22 months
CCI
Presence of comorbidities
Measured: 22 months
Clinical profile
General information on MG type, antibody profile, sociodemographic information, MG-specific symptoms, pharmacological therapy
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start7 Jun 2023
- Primary completion12 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718855
- Sponsor's protocol ID
- MYCOG
- Acronym
- MYCOG
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functioning in People With Myasthenia Graivs: Impact on Daily Life Activities, Work, Disability and Quality of Life
- ClinicalTrials.gov ID
- NCT06718855
- Acronym / sponsor ID
- MYCOG / MYCOG
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Cognitive Functioning, Disability, Activities of Daily Living, Quality of Life, Anxiety, Comorbidities, Work
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Italian speakers, already followed at Besta Institute
Key inclusion criteria (4 listed)
- Patients with MG,
- followed-up at Besta institute
- aged 18-99,
- able to understand Italian language;
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GEMS
Time frame: 22 months
Global examination of cognitive functioning
10 secondary outcomes
CRIq
Time frame: 22 months
ENB-3
Time frame: 22 months
MG-DIS
Time frame: 22 months
MG-QOL15
Time frame: 22 months
MG-ADL
Time frame: 22 months
WPAI-GH
Time frame: 22 months
HADS
Time frame: 22 months
FSS
Time frame: 22 months
CCI
Time frame: 22 months
Clinical profile
Time frame: 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GEMS (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.