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NCT Number: NCT06516016

Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages

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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Key information

Conditions

Neurodegenerative Diseases Nervous System Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pitié Salpêtrière Hospital

Paris, France

Location contact

Jean-Christophe CORVOL, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria :
  • 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
  • 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
  • For controls only :
  • Absence of symptoms or diagnosis of neurodegenerative disease (or criteria corresponding to at risk group)
  • 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.

Treatment and study plan

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.

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.

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.

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.

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.

Voice Recording

Other

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

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.

Blood sampling, skin biopsy, excreta sampling, lumbar puncture

Biological

Experimental analyses, genetic and multi-OMIC analyses for biomarker research.

Primary outcomes

  1. Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals

    Time frame: 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

Secondary outcomes

  1. Intra-individual change in trajectory profiles determined by multimodal analysis

    Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5

    Determination by individual parameters form multimodal analysis

  2. Rate and mean time to symptomatic conversion/progression

    Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5

    Conversion/progression defined according to international criteria for the clinical diagnosis of each disease

  3. Mean time of onset in genetically presymptomatic individuals

    Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5

    Estimated time to onset in genetic presymptomatic individuals from the average age at diagnosis among affected family members

  4. Rate of change for each study marker

    Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5

    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

  5. Rate of change in the self-administered questionnaires

    Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5

    Changes in the self-administered questionnaires on motivation, barriers and psychology

  6. Rate of change in consumption of information issued from Consultations, hospitalizations and medication prescriptions

    Time frame: From Year -10 to Year 10 (annual update)

    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.

  7. Time to loss of autonomy

    Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5

    Rate of change from baseline of at least 0.1 in the utility index from EQ-5D-51

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre GEORGES FRANCOIS

CONTACT

[email protected]

01 57 27 40 00

Sponsors and collaborators

Lead sponsor

Paris Brain Institute (ICM)

Other

Registry information

Acronym: NEUROPREMS

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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