CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05671055
• Other study ID #: ICO-S-001
• Status: Completed
• Start date: January 7, 2023
• Est. completion date: December 6, 2023

Study information

• Verified date: December 2023
• Source: icometrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study will investigate the correlation between objective and subjective cognition in multiple sclerosis. The study will also investigate the impact of covariates such as fatigue and depression, the relationship with the Expanded Disability Status Scale (EDSS) and brain volumetrics as measured on magnetic resonance imaging (MRI). Additionally, the study will provide insights into patients' experiences with cognition, and the usability of the used objective cognitive assessments.

Description:

Cognitive impairment is a significant burden that affects 43 to 70% of persons with multiple sclerosis (pwMS) 1. Cognitive problems have been observed in the earliest stages of multiple sclerosis (MS) and multiple studies have provided evidence for the predictive value of early cognitive impairment for future disease progression 2-6. However, cognitive function is not often discussed with pwMS or routinely assessed by healthcare providers (HCPs) leading to sub-optimal treatment of cognitive problems in MS 7. Furthermore, cognitive dysfunction that can be reliably detected by objective measures is poorly recognized by pwMS, resulting in a disconnect between objective and subjective measures of cognitive function 8-10.

The present study will investigate the correlation between what cognitive problems people with MS perceive and what objective cognitive testing actually shows. This study will also provide insights about the presence of this disconnect in different strata of the Expanded Disability Status Scale (EDSS) 11, and the relationship with possible confounders (MS symptoms, fatigue, etc.) and brain volumetrics as measured on magnetic resonance imaging (MRI).

Study Design:

CogMS is an observational, cross-sectional, remote, real-world study of cognitive function in patients with multiple sclerosis. We will investigate the correlation between subjective and objective patient self-evaluations of cognitive function while also investigating the prevalence of objective cognitive impairment in different EDSS strata of pwMS. MS patients will be stratified by EDSS to evaluate the correlation between objective and subjective cognition in three different EDSS strata (EDSS 0 - 2; 2.5 - 3.5; 4.0 - 5.5) and the occurrence of objective cognitive dysfunction in these EDSS stages of MS.

All data will be captured using the icompanion app in a remote, non-clinical setting (i.e., patient's home) within three weeks of patient onboarding. In the icompanion app, patients will be asked to perform the icognition cognitive test battery together with patient-reported outcomes (PROs) for subjective cognition, MS symptoms, prEDSS, depression and fatigue. If available, a recent (max. 6 months) MRI scan will be provided from which volumetric measurements can be calculated using icometrix' icobrain software.

Finally, patients will be asked to answer questions on their experiences with cognition since diagnosis, their preferences and opinions about cognition as a treatment goal, and the usability of the icognition battery, and the preference compared to paper-based neuropsychological tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 6, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Providing a signed informed consent

• Aged between 18 and 65 years old

• MS diagnosis (CIS, RRMS)

• Absence of hand function problems which limit the use of a device like a smartphone

• No history of relapse with onset 30 days prior to start of study

• No other major neurological or psychiatric disorders

• No history of cognitive rehabilitation treatment

Exclusion Criteria:

• Disease duration longer than 15 years

• Patients with established cognitive disorders other than MS

• Drug and/or alcohol abuse

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Custom study version of icompanion app
Patients complete patient-reported outcomes on cognition and covariates, as well as objective cognitive tests through a version of icompanion app customized specifically for this study. Patients complete all assessments remotely in an at-home situation.

Locations

Country	Name	City	State
Belgium	GZA Antwerpen	Antwerpen
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	AZ Sint-Jan Brugge	Brugge
Belgium	UZ Brussel	Jette
Germany	University of Greifswald	Greifswald
United States	UCHealth	Aurora	Colorado
United States	Dent Neurologic Institute	Buffalo	New York
United States	The Boster Center for Multiple Sclerosis	Columbus	Ohio
United States	Texas Neurology	Dallas	Texas
United States	Brain Health Center of the Rockies	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
icometrix	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuro-QoL cognitive	The Neuro-QoL (Quality of Life in Neurological Disorders) is a patient-reported outcome for subjective cognitive problems Minimum and maximum values: 8-40 (t-score: 17.3-64.2). High scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)
Primary	icognition Symbol test score	The icognition Symbol test is a smartphone-based symbol substitution test for information processing speed Minimum and maximum values: to be determined by a separate study which is being finalised High scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)
Primary	icognition Dot test score	The icognition Dot test score is a smartphone-based test for visual working memory Minimum and maximum values: to be determined by a separate study which is being finalised High scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)
Primary	icognition Digit test score	The icognition Digit test score is a smartphone-based test for working memory Minimum and maximum values: to be determined by a separate study which is being finalised High scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)
Secondary	prEDSS	is a patient-reported outcome (PRO) version of the Expanded Disability Status Scale (EDSS), the current golden standard method for assessing disability (progression) in MS.; Minimum and maximum values: 0-10 Low scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)
Secondary	Neuro-QoL fatigue	Neuro-QoL Fatigue is a patient-reported outcome for fatigue Minimum and maximum values: 8-40 (t-score: 29.5-74.1). Low scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)
Secondary	Beck's depression inventory	The BDI is a 21-question multiple-choice self-report psychometric tests for measuring the severity of depression.; Minimum and maximum values: 0-63. Low scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)
Secondary	MRI volumetric variables	icobrain volumetric MRI measurements: whole brain volume and atrophy, grey matter volume and atrophy, lesion load, total lesion volume, volume of new lesions, volume of enlarging lesions, volume of shrinking lesions, lesion volume and volume changes assessed locally (i.e. juxtacortical, periventricular, deep white matter, infratentorial)	at time of enrolment in study (in case MRI of <6months is available)
Secondary	System usability score (cognitive smartphone-based tests)	Usability questionnaire	Single cross-sectional time-point (max 2 months after signing ICF)
Secondary	Preference icognition vs. paper-based assessments	Likert scale [0-5]	Single cross-sectional time-point (max 2 months after signing ICF)
Secondary	SymptoMScreen	Questionnaire assessing the severity of the twelve most common MS Symptoms Minimum and maximum values: 0-6 Low scores indicate better (desirable) self-reported health.	Single cross-sectional time-point (max 2 months after signing ICF)