Status:
NOT_YET_RECRUITING
Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
Lead Sponsor:
Paris Brain Institute (ICM)
Conditions:
Neurodegenerative Diseases
Eligibility:
All Genders
18-95 years
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 chang...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2034
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06516016
Start Date
September 1 2024
End Date
August 31 2034
Last Update
July 23 2024
Active Locations (1)
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1
Pitié Salpêtrière Hospital
Paris, France