An observational study in Neurodegenerative Diseases, sponsored by Paris Brain Institute (ICM). Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Paris Brain Institute (ICM) · Observational
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.
370 studies on the registry are indexed under Neurodegenerative Diseases; 145 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 175 across 154 observational studies indexed under Neurodegenerative Diseases.
Browse Neurodegenerative Diseases studies →Paris Brain Institute (ICM) is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will focus on subjects potentially at high risk of developing a degenerative disease, compared to a control population of healthy volunteers and relatives with no evidence of genetic mutation under study, radiologically isolated syndrome (RIS), Idiopathic rapid eye-movement (REM) sleep behavior disorder (iRBD) and abnormal elevated levels of protein ptau217.
For all participants :
For presymptomatic participants only :
For controls only :
Clinical symptoms fulfilling the criteria of a neurodegenerative disease (see table in criteria section)
* 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)
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
* 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)
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
\[18F\]DPA-714 will be injected intravenously as a 1 minute intravenous bolus injection and dynamic PET acquisition will last 90 min. The aim is the quantification of the neuroimmune reaction during neuroinflammation process.
Brain MRI will aim at providing imaging biomarkers which will allow evaluating brain structure, microstructure, iron load, myelin, neurodegeneration of the substantia nigra and locus coeruleus, functional connectivity, brain perfusion and the glymphatic system.
Recording eye movements in a controlled environment (requiring no specific room or area) in binocular vision at a frequency \> 500Hz, while retaining infrared video footage of eye movements for high-quality clinical monitoring.
Recording brain magnetic activity using the Elekta Neuromag® TRIUX Magnetoencephalograph ; The participant will be comfortably seated in an adjustable-height chair. The device is enclosed in a shielded room isolated from external electric and magnetic fields to measure the extremely weak magnetic activities produced by the brain.
The acquisition of kinematic gait parameters will be achieved ; markers are positioned on the different segments of members, recognized by a camera system positioned on the walls. Neurophysiologic muscular activity of the lower limbs will also be recorded.
Participants will be recorded during a single session at every visit upon baseline with a professional quality head mounted microphone.
Participants will complete standard sleep questionnaires before the visit and perform neurophysiological tests including cognitive tasks before and after the sleep recording.
Experimental analyses, genetic and multi-OMIC analyses for biomarker research.
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
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Intra-individual change in trajectory profiles determined by multimodal analysis
Determination by individual parameters form multimodal analysis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Plan to share: No
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Paris Brain Institute (ICM)