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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 800 presymptomatic participants |
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| 200 healthy volunteers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET | Radiation | [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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria :
For all participants :
For presymptomatic participants only :
For controls only :
Exclusion Criteria :
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre GEORGES FRANCOIS | Contact | 01 57 27 40 00 | riph@icm-institute.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié Salpêtrière Hospital | Paris | France |
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| MRI 3T | Other | 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. |
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| Oculomotricity assessment | Other | 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. |
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| Magnetoencephalography assessment | Other | 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. |
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| Body posture and gait assessment | Other | 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. |
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| Voice recording | Other | Participants will be recorded during a single session at every visit upon baseline with a professional quality head mounted microphone. |
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| Video-polysomnography | Other | Participants will complete standard sleep questionnaires before the visit and perform neurophysiological tests including cognitive tasks before and after the sleep recording. |
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| Blood sampling, skin biopsy, excreta sampling, lumbar puncture | Biological | Experimental analyses, genetic and multi-OMIC analyses for biomarker research. |
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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 |
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011187 | Posture |
| D001800 | Blood Specimen Collection |
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D003943 | Diagnostic Techniques, Neurological |
| D013812 | Therapeutics |
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