Multiple sclerosis MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: [18F]UCB-H
Product Code: [18F]UCB-H
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]UCB-H
CAS Number: 1774352-40-7
Current Sponsor code: [18F]UCB-H
Other descriptiv
Sponsors
Service de Neurologie, CHU Liège
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants, selected at the specialized MS outpatient clinic of the CHU of Liège, consist of patients with a diagnosis of RRMS according to Mc Donald criteria 2017, with no evidence of clinical progression. In order to eschew interference of recurrent relapses, patients have to be relapse-free for at least 6 months at the time of inclusion. Other inclusion criteria include: - Willingness to participate to the study - Good general health (except for MS) - Visual and auditory acuity adequate for testing - Completed at least six grades of education (i.e., exclude mental retardation) In addition, healthy control participants, matched with patients for sex, age and socio-cultural level will be recruited through advertising in local newspapers, radios, communities, sport clubs and word of mouth. Inclusion criteria are the same as for patients, with the exception of MS. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Presence or history of neurological diseases other than MS, psychiatry diseases, major traumatic brain injury, major surgery , uncontrolled infection or medical condition, Female patient without contraception, physical or behavioural state incompatible with the current protocol (including MR compatibility, pregnancy, tutorship or guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to assess regional brain synaptic density in MS patients of various duration and to determine whether a significant regional decrease in synaptic density can be detected, at the individual level, in comparison to age-matched healthy participants, using PET scanning and [18F]-UCB-H. ;Secondary Objective: Not applicable;Primary end point(s): (1) Acquisition of data for 50 participants, (2) Last inclusion in the trial (3)Map of significant regional differences in synaptic density, R1, R2*, MT and QSM beween MS patients and normal controls.;Timepoint(s) of evaluation of this end point: Primary endpoint : Final analysis of data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium
Contacts
Public ContactGIGA-CRC in vivo imaging
University of Liège
Outcome results
None listed