Remyelination in Multiple Sclerosis: a PET-MR Longitudinal Study Investigating Individual Profiles of Myelin Repair and the Contribution of Neuroinflammation

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 6, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how some patients with Multiple Sclerosis (MS) can regenerate myelin, the protective covering of nerves that is damaged by the disease. The researchers want to understand why only some patients can successfully repair this damage while others cannot. They will use advanced imaging techniques to look at the brain and measure both myelin repair and inflammation. Additionally, they will analyze blood samples from participants to see how immune cells might affect the ability to repair myelin.

To participate in the study, individuals must be between 18 and 55 years old and have been diagnosed with either relapsing or progressive forms of MS, with certain criteria related to disease duration and MRI findings. Healthy volunteers within the same age range can also take part. Participants can expect to undergo imaging tests and provide blood samples, helping researchers gain insights that could lead to better treatments for MS in the future. It's important to note that there are specific health conditions and recent treatments that may exclude individuals from participating, so eligibility will be assessed carefully.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• RRMS patients:
• • 1. Age between 18 and 55 years old
• • 2. RRMS according to the 2017 Mc Donald criteria
• • 3. Less than 5 years of disease duration
• • 4. At least 9 supra-tentorial white matter lesions on T2/FLAIR MRI
• • 5. Last treatment with methylprednisolone should have been performed at least 1 month before PET examinations
• • 6. Interferon-beta, glatiramere acetate and oral first line therapy will such as dimethylfumarate or teriflunomide will be admitted
• • 7. Affiliation to a social security scheme or beneficiary of such a scheme (Except "Aide Médicale d'Etat")
• Progressive MS patients:
• • 1. Age between 18 and 55 years old
• • 2. Progressive MS (primary or secondary progressive MS) according to the 2017 Mc Donald criteria
• • 3. Less than 10 years of disease duration in the progressive phase
• • 4. At least 9 supra-tentorial white matter lesions on T2/FLAIR MRI
• • 5. Interferon-beta, glatiramere acetate and oral first line therapy will such as dimethylfumarate or teriflunomide will be admitted
• • 6. Affiliation to a social security scheme or beneficiary of such a scheme (except "Aide Médicale d'Etat")
• Healthy volunteers:
• • 1. Age between 18 and 55 years old
• • 2. Without any evolutive pathology
• • 3. Able to understand the study objectives and procedures
• • 4. Affiliation to a social security scheme or beneficiary of such a scheme (except "Aide Médicale d'Etat")
• Exclusion Criteria:
• For all participants:
• • 1. Any reasons, which does not allow to perform MRI, including claustrophobia, the implant of a pace maker or the presence of an intra-ocular foreign body (a contra-indication questionnaire will be filled in beforehand)
• • 2. PET for clinical research already done within the last 12 months
• • 3. Low Affinity Binding profile (TSPO polymorphism analyzed at screening visit)
• • 4. Pregnancy, breast-feeding, lack of efficient contraception
• • 5. Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary or cardiac disease, or any other chronic neurological diseases
• • 6. Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)
• • 7. Know hypersensitivity to Myelin PET : \[18F\]-Florbetaben
• • 8. Patient under legal protection
• Additional exclusion criteria for patients:
• • 1. Treatment with cyclophosphamide, mitoxantrone, fingolimod, cladribine, alemtuzumab, anti CD20 antibodies or natalizumab will not be admitted. These treatments may be administered after the Baseline visit.
• • 2. Known allergy to gadoteric acid
• • 3. Allergies (seafood, pollinosis, urticarial) having required a medical intervention
• • 4. Severe renal insufficiency (creatinine clearance \< 60mL/min).