Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurodegenerative Diseases
- Sponsor
- Paris Brain Institute (ICM)
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals
Time Frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
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
Secondary Outcomes
- Mean time of onset in genetically presymptomatic individuals(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(From Year -10 to Year 10 (annual update))
- Time to loss of autonomy(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Rate and mean time to symptomatic conversion/progression(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Intra-individual change in trajectory profiles determined by multimodal analysis(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Rate of change for each study marker(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Rate of change in the self-administered questionnaires(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)