Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
Not yet recruiting
- Conditions
- Neurodegenerative Diseases
- Interventions
- Radiation: PETOther: MRI 3TOther: Oculomotricity assessmentOther: Magnetoencephalography assessmentOther: Body posture and gait assessmentOther: Voice recordingOther: Video-polysomnographyBiological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture
- 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
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
- Arm && Interventions
Group Intervention Description 800 presymptomatic participants Blood sampling, skin biopsy, excreta sampling, lumbar puncture * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers Magnetoencephalography assessment * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 800 presymptomatic participants PET * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 800 presymptomatic participants Oculomotricity assessment * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 800 presymptomatic participants MRI 3T * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 800 presymptomatic participants Voice recording * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 800 presymptomatic participants Video-polysomnography * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers MRI 3T * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers Oculomotricity assessment * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 800 presymptomatic participants Magnetoencephalography assessment * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 800 presymptomatic participants Body posture and gait assessment * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers Blood sampling, skin biopsy, excreta sampling, lumbar puncture * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers PET * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers Video-polysomnography * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers Body posture and gait assessment * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection) 200 healthy volunteers Voice recording * Visit interview * Neurological evaluation (NeuroPrems Scale and Self-administered REDCap questionnaires) * Psychological evaluation (Motivation, life trajectories and experiencies and semi-structured interview) * Cognition and behavior evaluation (Neuropsychological battery and Self-administered REDCap QR) * Imaging (MRI 3T and PET DPA-714) * Neurophysiology (Eye movement recording, Magnetoencephalography, Body posture and gait recording, voice and language recording) * Skin aging (Skin quantitative elasticity assessment) * Sleep (Videopolysomnography) * Biosampling (Blood draw, lumbar puncture, saliva sampling, skin biopsy, nasal brush and tear fluid collection)
- 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