Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
NEUROPREMS
1 other identifier
observational
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2034
July 23, 2024
June 1, 2024
10 years
June 6, 2024
July 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals
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
Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Secondary Outcomes (7)
Intra-individual change in trajectory profiles determined by multimodal analysis
Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate and mean time to symptomatic conversion/progression
Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Mean time of onset in genetically presymptomatic individuals
Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change for each study marker
Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change in the self-administered questionnaires
Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
- +2 more secondary outcomes
Study Arms (2)
800 presymptomatic participants
* 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)
200 healthy volunteers
* 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)
Interventions
\[18F\]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.
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.
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.
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.
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.
Participants will be recorded during a single session at every visit upon baseline with a professional quality head mounted microphone.
Participants will complete standard sleep questionnaires before the visit and perform neurophysiological tests including cognitive tasks before and after the sleep recording.
Experimental analyses, genetic and multi-OMIC analyses for biomarker research.
Eligibility Criteria
The study will focus on subjects potentially at high risk of developing a degenerative disease, compared to a control population of healthy volunteers and relatives with no evidence of genetic mutation under study, radiologically isolated syndrome (RIS), Idiopathic rapid eye-movement (REM) sleep behavior disorder (iRBD) and abnormal elevated levels of protein ptau217.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pitié Salpêtrière Hospital
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2024
First Posted
July 23, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
August 31, 2034
Study Completion (Estimated)
August 31, 2034
Last Updated
July 23, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share