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Cognition and MRI Markers in MS Patients With Aubagio® Treatment (AUBACOG)

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ClinicalTrials.gov Identifier: NCT03768648
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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. 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®.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Other: Clinical assessment Other: Ecological evaluation Other: Neuropsychological evaluation Other: Psychological evaluation Device: MRI Evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patient
RRMS diagnosis according to McDonald criteria (Polman et al.,2005);
Other: Clinical assessment
EDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded

Other: Ecological evaluation
Virtual reality task : Urban DailyCog© and Actual reality

Other: Neuropsychological evaluation
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function

Other: Psychological evaluation
questionnaires for depression, anxiety and fatigue

Device: MRI Evaluation
morphological MRI and resting state functional MRI (fMRI)

Active Comparator: Control
40 Healthy controls (HC)
Other: Ecological evaluation
Virtual reality task : Urban DailyCog© and Actual reality

Other: Neuropsychological evaluation
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function

Other: Psychological evaluation
questionnaires for depression, anxiety and fatigue

Device: MRI Evaluation
morphological MRI and resting state functional MRI (fMRI)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change of composite z cognitive score based on individual neuropsychological scores [ Time Frame: At baseline (day 0) and at 24 months from baseline ]
    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.

  2. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • 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)

Exclusion Criteria:

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,
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768648


Contacts
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Contact: Bruno BROCHET, Prof 05 56 79 55 21 ext +33 bruno.brochet@chu-bordeaux.fr
Contact: Mathilde DELOIRE, Prof 05 57 82 12 75 ext +33 mathilde.deloire@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux - Service de neurologie Recruiting
Bordeaux, France
Contact: Bruno BROCHET, Prof    05 56 79 55 21 ext +33    bruno.brochet@chu-bordeaux.fr   
Contact: Mathilde DELOIRE, PhD    05 57 82 12 75 ext +33    mathilde.deloire@chu-bordeaux.fr   
Principal Investigator: Bruno BROCHET, Prof         
Sub-Investigator: Aurélie RUET, MD         
Sub-Investigator: Jean-Christophe OUALLET, MD         
Sub-Investigator: Cécile DULAU, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Bruno BROCHET, Prof CHU - Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03768648     History of Changes
Other Study ID Numbers: CHUBX 2016/02
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
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

Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases