Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages

NCT06516016 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-07-23

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Paris Brain Institute (ICM)

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2034-08-31
Completion
2034-08-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516016 on ClinicalTrials.gov