Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
NCT Number: NCT06516016
Acronym: NEUROPREMS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurodegenerative Diseases
Interventions: RADIATION: PET|OTHER: MRI 3T|OTHER: Oculomotricity assessment|OTHER: Magnetoencephalography assessment|OTHER: Body posture and gait assessment|OTHER: Voice recording|OTHER: Video-polysomnography|BIOLOGICAL: Blood sampling, skin biopsy, excreta sampling, lumbar puncture
Sponsor: Paris Brain Institute (ICM)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2034-08-31
Locations: Pitié Salpêtrière Hospital, Paris, France

Summary:
NeuroPrems is a prospective, monocentric, longitudinal, not relating to a medicinal product for human use, non-randomized, non-controlled research. The study mainly aims to identify longitudinal changes and events in multimodal markers of neurodegeneration and neuroinflammation during the presymptomatic phases of neurodegenerative diseases.

Primary Outcome Measures: Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals, Clinical markers will be: neurological and neuropsychological testing, and questionnaires; Neurophysiological markers will link functional brain networks and cognitive processes by using MEG, kinematic or eye movement recordings; Anatomical markers will be: cerebral MRI, glymphatic imaging, PET and skin elasticity; Molecular markers will be: blood, CSF, skin cells, iPSC derived biomarkers, transcriptomic, proteomic and metabolomic signatures, Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Secondary Outcome Measures: Intra-individual change in trajectory profiles determined by multimodal analysis, Determination by individual parameters form multimodal analysis, Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5|Rate and mean time to symptomatic conversion/progression, Conversion/progression defined according to international criteria for the clinical diagnosis of each disease, Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5|Mean time of onset in genetically presymptomatic individuals, Estimated time to onset in genetic presymptomatic individuals from the average age at diagnosis among affected family members, Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5|Rate of change for each study marker, Period of changes defined (1) as breakpoints in the longitudinal evolution; (2) early, intermediate or late progression for each marker in the whole cohort and for each pathological group, Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5|Rate of change in the self-administered questionnaires, Changes in the self-administered questionnaires on motivation, barriers and psychology, Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5|Rate of change in consumption of information issued from Consultations, hospitalizations and medication prescriptions, Data from SNDS will be extracted during a 10-year period before and 10-year after the cohort entry. This follow-up should allow for a better understanding of when conversion occurs and to compare pathologies which involve a fairly broad spectrum of evolution., From Year -10 to Year 10 (annual update)|Time to loss of autonomy, Rate of change from baseline of at least 0.1 in the utility index from EQ-5D-51, Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5