NCT06516016

Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Paris Brain Institute (ICM) · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neurodegenerative Diseases

Interventions

Type	Name	Description
RADIATION	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.
OTHER	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.
OTHER	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.
OTHER	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.
OTHER	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.
OTHER	Voice recording	Participants will be recorded during a single session at every visit upon baseline with a professional quality head mounted microphone.
OTHER	Video-polysomnography	Participants will complete standard sleep questionnaires before the visit and perform neurophysiological tests including cognitive tasks before and after the sleep recording.
BIOLOGICAL	Blood sampling, skin biopsy, excreta sampling, lumbar puncture	Experimental analyses, genetic and multi-OMIC analyses for biomarker research.

Timeline

• Start date: 2024-09-01
• Primary completion: 2034-08-31
• Completion: 2034-08-31
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: France