Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages

Not yet recruiting

• Conditions: Neurodegenerative Diseases

• Registration Number: NCT06516016
• Lead Sponsor: Paris Brain Institute (ICM)

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Study Start: 2024-09-01
• Primary Completion: 2034-08-31
• Study Completion: 2034-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals	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 Outcome Measures

Name	Time	Method
Mean time of onset in genetically presymptomatic individuals	Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5	Estimated time to onset in genetic presymptomatic individuals from the average age at diagnosis among affected family members
Rate of change in consumption of information issued from Consultations, hospitalizations and medication prescriptions	From Year -10 to Year 10 (annual update)	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.
Time to loss of autonomy	Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5	Rate of change from baseline of at least 0.1 in the utility index from EQ-5D-51
Rate and mean time to symptomatic conversion/progression	Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5	Conversion/progression defined according to international criteria for the clinical diagnosis of each disease
Intra-individual change in trajectory profiles determined by multimodal analysis	Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5	Determination by individual parameters form multimodal analysis
Rate of change for each study marker	Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5	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
Rate of change in the self-administered questionnaires	Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5	Changes in the self-administered questionnaires on motivation, barriers and psychology

Trial Locations

Locations (1)

Pitié Salpêtrière Hospital; 🇫🇷 Paris, France