Multiple Sclerosis, Relapsing-RemittingAUBACOGNCT03768648
Cognition and MRI Markers in MS Patients With Aubagio® Treatment
A study testing Clinical assessment, Ecological evaluation and Neuropsychological evaluation in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Clinical assessment, Ecological evaluation and Neuropsychological evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2019to 23 Feb 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- PATIENTS
- Male or female
- Age 18-60 years
- RRMS diagnosis according to McDonald criteria (Polman et al., 2005);
- Treated with Aubagio® (Indication for first line therapy)
- Native French speaking
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- Being affiliated to health insurance
- Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)
- HEALTHY CONTROLS
- Male or Female,
- Age 18-60 years
- Willing to participate and to sign informed consent.
- Being affiliated to health insurance
- Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)
Who cannot join
- PATIENTS
- History of neurological disease and/or other neurological diseases,
- Psychiatric comorbidity including severe depression according to DSM-IV,
- Alcohol or other addiction to toxic,
- Disabling visual or motor problems preventing participation to neuropsychological assessments,
- Acquisition disorders : Dyslexia, Dysphasia, Dyscalculia and dyspraxia,
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- Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 30 days
- Relapse since less than one month,
- Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily,
- Prior neuropsychological testing with the same tests less than 6 months
- Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
- Illiteracy, is unable to count or to read
- Pregnant or breastfeeding women
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
- HEALTHY CONTROLS
- History of neurological disease and/or neurological diseases
- Psychiatric comorbidity including severe depression according to DSM-IV;
- Alcohol or other toxic addiction;
- Known cognitive complaint or neuropsychological affection
- Hypnotic or anxiolytic or antidepressive treatment,
- Prior neuropsychological testing with the same tests less than 6 months
- Acquisition disorders: Dyslexia, Dysphasia, Dyscalculia and dyspraxia,
- Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily,
- Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
- Illiteracy, is unable to count or to read
- Pregnant or breastfeeding women
- Person concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Ecological evaluations, recent and innovative way to assess cognitive functions with the true impact of cognitive impairment in everyday daily life of patients. One goal of an ecological test could be to identify MS patients in whom cognitive impairment has a strong interaction with daily life. Different type of ecological evaluation have been recently proposed in MS, including assessment cognitive tasks in a virtual reality environment using the Urban DailyCog® software developed in our laboratory (Hamel et al, 2015). Virtual reality environment assessments are promising in detecting cognitive impairment while providing friendly assessments for patients and simulating daily activities. . Cognitive dysfunction is correlated with white matter diffuse injury in relapsing-remitting MS (RRMS) patients and brain atrophy However, the relationships between structural brain damage and brain connectivity with cognitive functioning assessed by ecological evaluation are also unknown. The use of new techniques for morphological and functional MRI can study the contribution of diffuse white matter (WM) alteration and diffuse gray matter (GM) alterations in cognitive impairment and on their evolution.
The objectives are to evaluate the ecological assessment (Urban DailyCog® and actual reality) to detect cognitive impairment in everyday daily life of patients and their changes and to investigate structural WM and GM damages and the dynamic of functional connectivity for explaining and predicting cognitive disability during two years in RRMS patients treated by the same treatment Aubagio®.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Clinical assessment, Ecological evaluation, Neuropsychological evaluation, Psychological evaluation, MRI Evaluation
- Keywords
- Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Demyelinating Diseases, Immune System Diseases, Nervous System Diseases, Pathologic Processes, cognitive impairment, ecological assessment, brain MRI
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Demyelinating Diseases, Immune System Diseases, Nervous System Diseases, Pathologic Processes, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
EDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded
Ecological evaluationOther
Virtual reality task : Urban DailyCog© and Actual reality
Neuropsychological evaluationOther
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
Psychological evaluationOther
questionnaires for depression, anxiety and fatigue
MRI EvaluationDevice
morphological MRI and resting state functional MRI (fMRI)
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | RRMS diagnosis according to McDonald criteria (Polman et al.,2005); Receives: Other: Clinical assessment; Other: Ecological evaluation; Other: Neuropsychological evaluation; Other: Psychological evaluation; Device: MRI Evaluation |
| Control | Active comparator | 40 Healthy controls (HC) Receives: Other: Ecological evaluation; Other: Neuropsychological evaluation; Other: Psychological evaluation; Device: MRI Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of composite z ecological score based on individual ecological scores.
The composite z ecological score is the average of z ecological scores of virtual reality task (Urban DailyCog©) and actual reality tests. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time (baseline and 2 years).
Measured: At baseline (day 0) and at 24 months from baseline
Secondary outcomes (2)
Change of composite z cognitive score based on individual neuropsychological scores
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time. Individual neuropsychological scores included in composite z cognitive score : the Alertness subtest, the divided attention subtest and the visual-scanning subtest from the TAP, The Symbol-digit-modalities-test, the Paced-Auditory-Serial-Addition-Test 3s, reversed span, the Stroop test, the Verbal fluency, Trail Making test, the California Verbal memory learning test and the Brief visual memory test -revised.
Measured: At baseline (day 0) and at 24 months from baseline
Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity
The composite z cognitive score and the composite ecological score are the average of z individual cognitive and ecological scores. The score from each cognitive and ecological test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time.
Measured: At baseline (day 0) and at 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start21 May 2019
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Aurélie RUET, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768648
- Sponsor's protocol ID
- CHUBX 2016/02
- Other IDs
- 2018-A02785-50
- Acronym
- AUBACOG
- Status last verified
- Mar 2023
- First submitted
- 4 Dec 2018
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fournet A, Munsch F, Koubiyr I, Vidal JP, Morell-Ortega S, Saubusse A, Charre-Morin J, Lataste KK, Lavielle A, Bei Z, Coupe P, Barbeau EJ, Kumar VJ, Hornberger M, Dousset V, Brochet B, Manjon JV, Ruet A, Tourdias T. Interthalamic adhesion alterations in multiple sclerosis: associations with thalamic damage and cognition. J Neurol. 2026 Aug 20;273(9):535. doi: 10.1007/s00415-026-14069-5.
PubMed 42624921
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting
- ClinicalTrials.gov ID
- NCT03768648
- Acronym / sponsor ID
- AUBACOG / CHUBX 2016/02
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Demyelinating Diseases, Immune System Diseases, Nervous System Diseases, Pathologic Processes, cognitive impairment, ecological assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 21 May 2019 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 7 Dec 2018 (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.
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Ecological evaluations, recent and innovative way to assess cognitive functions with the true impact of cognitive impairment in everyday daily life of patients. One goal of an ecological test could be to identify MS patients in whom cognitive impairment has a strong interaction with daily life. Different type of ecological evaluation have been recently proposed in MS, including assessment cognitive tasks in a virtual reality environment using the Urban DailyCog® software developed in our laboratory (Hamel et al, 2015). Virtual reality environment assessments are promising in detecting cognitive impairment while providing friendly assessments for patients and simulating daily activities. . Cognitive dysfunction is correlated with white matter diffuse injury in relapsing-remitting MS (RRMS) patients and brain atrophy However, the relationships between structural brain damage and brain connectivity with cognitive functioning assessed by ecological evaluation are also unknown. The use of new techniques for morphological and functional MRI can study the contribution of diffuse white matter (WM) alteration and diffuse gray matter (GM) alterations in cognitive impairment and on their evolution.
The objectives are to evaluate the ecological assessment (Urban DailyCog® and actual reality) to detect cognitive impairment in everyday daily life of patients and their changes and to investigate structural WM and GM damages and the dynamic of functional connectivity for explaining and predicting cognitive disability during two years in RRMS patients treated by the same treatment Aubagio®.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: Clinical assessment, Other: Ecological evaluation, Other: Neuropsychological evaluation, Other: Psychological evaluation, Device: MRI EvaluationRRMS diagnosis according to McDonald criteria (Polman et al.,2005); |
| Control | Active comparator | Other: Ecological evaluation, Other: Neuropsychological evaluation, Other: Psychological evaluation, Device: MRI Evaluation40 Healthy controls (HC) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- PATIENTS
- Male or female
- Age 18-60 years
- RRMS diagnosis according to McDonald criteria (Polman et al., 2005);
- Treated with Aubagio® (Indication for first line therapy)
Key exclusion criteria (27 listed)
- PATIENTS
- History of neurological disease and/or other neurological diseases,
- Psychiatric comorbidity including severe depression according to DSM-IV,
- Alcohol or other addiction to toxic,
- Disabling visual or motor problems preventing participation to neuropsychological assessments,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentEDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded | Other | patient |
| Ecological evaluationVirtual reality task : Urban DailyCog© and Actual reality | Other | Control, patient |
| Neuropsychological evaluationcognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function | Other | Control, patient |
| Psychological evaluationquestionnaires for depression, anxiety and fatigue | Other | Control, patient |
| MRI Evaluationmorphological MRI and resting state functional MRI (fMRI) | Device | Control, patient |
Primary outcome
Change of composite z ecological score based on individual ecological scores.
Time frame: At baseline (day 0) and at 24 months from baseline
The composite z ecological score is the average of z ecological scores of virtual reality task (Urban DailyCog©) and actual reality tests. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time (baseline and 2 years).
2 secondary outcomes
Change of composite z cognitive score based on individual neuropsychological scores
Time frame: At baseline (day 0) and at 24 months from baseline
Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity
Time frame: At baseline (day 0) and at 24 months from baseline
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 20 May 2026.
- Derived from this study: PubMed 42624921Fournet A, Munsch F, Koubiyr I, Vidal JP, Morell-Ortega S, Saubusse A, Charre-Morin J, Lataste KK, Lavielle A, Bei Z, Coupe P, Barbeau EJ, Kumar VJ, Hornberger M, Dousset V, Brochet B, Manjon JV, Ruet A, Tourdias T. Interthalamic adhesion alterations in multiple sclerosis: associations with thalamic damage and cognition. J Neurol. 2026 Aug 20;273(9):535. doi: 10.1007/s00415-026-14069-5.
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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.
Aurélie RUET, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment, Ecological evaluation and Neuropsychological evaluation in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Bordeaux at 1 site in France.
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 14 inclusion and 27 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 20 May 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 France. 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?
Change of composite z ecological score based on individual ecological scores. (time frame: At baseline (day 0) and at 24 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768648, which also lists 1 linked publication.
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 20 May 2026.