Neurodegenerative DiseasesNEUROPREMSNCT06516016
Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
An observational study of Neurodegenerative Diseases, run by Paris Brain Institute (ICM) at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- PET, MRI 3T and Oculomotricity assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 31 Aug 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- PET, MRI 3T, Oculomotricity assessment, Magnetoencephalography assessment, Body posture and gait assessment
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETRadiation
[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 3TOther
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 assessmentOther
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 assessmentOther
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 assessmentOther
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 recordingOther
Participants will be recorded during a single session at every visit upon baseline with a professional quality head mounted microphone.
Video-polysomnographyOther
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 punctureBiological
Experimental analyses, genetic and multi-OMIC analyses for biomarker research.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Radiation: PET; Other: MRI 3T; Other: Oculomotricity assessment; Other: Magnetoencephalography assessment; Other: Body posture and gait assessment; Other: Voice recording; Other: Video-polysomnography; Biological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture | |
| 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) Receives: Radiation: PET; Other: MRI 3T; Other: Oculomotricity assessment; Other: Magnetoencephalography assessment; Other: Body posture and gait assessment; Other: Voice recording; Other: Video-polysomnography; Biological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Determination by individual parameters form multimodal analysis
Measured: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate and mean time to symptomatic conversion/progression
Conversion/progression defined according to international criteria for the clinical diagnosis of each disease
Measured: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Mean time of onset in genetically presymptomatic individuals
Estimated time to onset in genetic presymptomatic individuals from the average age at diagnosis among affected family members
Measured: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change for each study marker
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
Measured: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change in the self-administered questionnaires
Changes in the self-administered questionnaires on motivation, barriers and psychology
Measured: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change in consumption of information issued from Consultations, hospitalizations and medication prescriptions
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.
Measured: From Year -10 to Year 10 (annual update)
Time to loss of autonomy
Rate of change from baseline of at least 0.1 in the utility index from EQ-5D-51
Measured: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2034 (estimated)
- Study completion31 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paris Brain Institute (ICM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516016
- Sponsor's protocol ID
- 2024-A00824-43
- Acronym
- NEUROPREMS
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
- ClinicalTrials.gov ID
- NCT06516016
- Acronym / sponsor ID
- NEUROPREMS / 2024-A00824-43
- Conditions
- Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Paris Brain Institute (ICM)University, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2034 (estimated)
- Study completion
- 31 Aug 2034 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 800 presymptomatic participants | – | Radiation: PET, Other: MRI 3T, Other: Oculomotricity assessment, Other: Magnetoencephalography assessment, Other: Body posture and gait assessment, Other: Voice recording, Other: Video-polysomnography, Biological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture* 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 | – | Radiation: PET, Other: MRI 3T, Other: Oculomotricity assessment, Other: Magnetoencephalography assessment, Other: Body posture and gait assessment, Other: Voice recording, Other: Video-polysomnography, Biological: Blood sampling, skin biopsy, excreta sampling, lumbar puncture* 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) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | 200 healthy volunteers, 800 presymptomatic participants |
| MRI 3TBrain 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 | 200 healthy volunteers, 800 presymptomatic participants |
| Oculomotricity assessmentRecording 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 | 200 healthy volunteers, 800 presymptomatic participants |
| Magnetoencephalography assessmentRecording 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 | 200 healthy volunteers, 800 presymptomatic participants |
| Body posture and gait assessmentThe 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 | 200 healthy volunteers, 800 presymptomatic participants |
| Voice recordingParticipants will be recorded during a single session at every visit upon baseline with a professional quality head mounted microphone. | Other | 200 healthy volunteers, 800 presymptomatic participants |
| Video-polysomnographyParticipants will complete standard sleep questionnaires before the visit and perform neurophysiological tests including cognitive tasks before and after the sleep recording. | Other | 200 healthy volunteers, 800 presymptomatic participants |
| Blood sampling, skin biopsy, excreta sampling, lumbar punctureExperimental analyses, genetic and multi-OMIC analyses for biomarker research. | Biological | 200 healthy volunteers, 800 presymptomatic participants |
Primary outcome
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
7 secondary outcomes
Intra-individual change in trajectory profiles determined by multimodal analysis
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate and mean time to symptomatic conversion/progression
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Mean time of onset in genetically presymptomatic individuals
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change for each study marker
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change in the self-administered questionnaires
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Rate of change in consumption of information issued from Consultations, hospitalizations and medication prescriptions
Time frame: From Year -10 to Year 10 (annual update)
Time to loss of autonomy
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases, run by Paris Brain Institute (ICM) at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre GEORGES FRANCOIS (01 57 27 40 00, riph@icm-institute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.