Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages (NEUROPREMS)

Paris Brain Institute (ICM)

Status: Not yet enrolling

Conditions: Neurodegenerative Diseases

Treatments: Other: Oculomotricity assessment; Biological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture; Radiation: PET; Other: Video-polysomnography; Other: Voice recording; Other: Body posture and gait assessment; Other: Magnetoencephalography assessment; Other: MRI 3T

Study type: Observational

Funder types: Other

Identifiers

NCT06516016

2024-A00824-43

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria :

   1. For all participants :

      • Male or female
      • Age ≥ 18 years
      • Signed Informed consent by the subject
      • Affiliated with a social security system or beneficiary of such a regime
      • Ability to undergo an MRI exam with Gadobutrol

   2. For presymptomatic participants only :

      • Absence of a diagnosis of neurodegenerative disease. And at least one of the criteria :
      • Known carrier or relative of a patient carrying a mutation in a causal or at-risk responsible for a neurodegenerative disease
      • Isolated REM sleep behavioral disorder
      • Radiological isolated syndrome
      • Abnormal brain protein aggregates

   3. For controls only :

      • Absence of symptoms or diagnosis of neurodegenerative disease (or criteria corresponding to at risk group)

2. Exclusion Criteria :

   • Clinical symptoms fulfilling the criteria of a neurodegenerative disease (see table in criteria section)
   • Refusal of blood draw or brain MRI
   • MRI contraindication (see criteria section)
   • Known allergy to gadoteric acid
   • Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)
   • Pregnancy or breastfeeding. For women in fertile age a urine pregnancy test will be performed before the MRI.
   • Inability to understand information about the protocol
   • Person deprived of their liberty by judicial or administrative decision
   • Person under legal protection (legal guardianship, tutelage or maintenance of justice)
   • Person without any protection and unable to consent
   • Other medical, neurological, psychiatric, or social conditions that in the investigator's opinion are likely to interfere with study conduct.

Trial design

1,000 participants in 2 patient groups

800 presymptomatic participants

Description:

* 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)

Treatment:

Other: MRI 3T

Other: Body posture and gait assessment

Other: Magnetoencephalography assessment

Other: Voice recording

Other: Video-polysomnography

Radiation: PET

Biological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture

Other: Oculomotricity assessment

200 healthy volunteers

Description:

* 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)

Treatment:

Other: MRI 3T

Other: Body posture and gait assessment

Other: Magnetoencephalography assessment

Other: Voice recording

Other: Video-polysomnography

Radiation: PET

Biological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture

Other: Oculomotricity assessment