Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages

Condition(s) studied

Investigational drug(s) / intervention(s)

PET: \[18F\]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.

MRI 3T: 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.

Oculomotricity assessment: 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.

Magnetoencephalography assessment: 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.

Body posture and gait assessment: 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.

Voice recording: Participants will be recorded during a single session at every visit upon baseline with a professional quality head mounted microphone.

Video-polysomnography: Participants will complete standard sleep questionnaires before the visit and perform neurophysiological tests including cognitive tasks before and after the sleep recording.

Blood sampling, skin biopsy, excreta sampling, lumbar puncture: Experimental analyses, genetic and multi-OMIC analyses for biomarker research.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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