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Clinical Trials/NCT06244875
NCT06244875
Not yet recruiting
Not Applicable

Collection Biologique Des Atteintes Neurocognitives

Assistance Publique - Hôpitaux de Paris0 sites3,000 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurocognitive Disorders
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
3000
Primary Endpoint
Identification of new biomarkers for neurodegenerative diseases
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The development of biological biomarkers reflecting neuropathology has enhanced the diagnostic precision of Alzheimer's disease over the past decade, compared to the clinical diagnosis that suffers from low specificity. Patients undergoing evaluation in specialized memory clinics suspected of major or minor neurocognitive disorder are notably examined through a lumbar puncture to measure beta-amyloid 42, beta-amyloid 40, total tau, and phosphorylated tau in the cerebrospinal fluid (CSF). The purpose of this clinico-biological collection is to better characterize the existing biomarkers used in clinical practice, as well as the development of new diagnostic or prognostic biomarkers for neurodegenerative diseases causing neurocognitive disorder (Alzheimer's disease, Lewy body disease, frontotemporal lobar degeneration, in particular).

The primary objective is to gain a better understanding of conventional biomarkers and to develop new diagnostic and prognostic biomarkers for neurocognitive diseases: establishing a prospective clinico-biological collection of patients evaluated in clinical practice for a neurocognitive disorder.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
February 1, 2044
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patient
  • Not under legal guardianship
  • Clinical indication for blood and cerebrospinal fluid (CSF) biomarkers measurement during a day hospital stay for Alzheimer's disease (beta-amyloid peptide, tau protein).
  • Signature of the research consent form.

Exclusion Criteria

  • Not affiliated with a social security scheme.
  • Patient under State Medical Aid (AME).

Outcomes

Primary Outcomes

Identification of new biomarkers for neurodegenerative diseases

Time Frame: Up to 10 years

Secondary Outcomes

  • Description of the level of usual biomarkers by type of dementia(Up to 10 years)
  • Evaluation of the relationship between biomarker levels and cognitive evolution measured in routine care(Up to 10 years)
  • Comparison of biomarker levels in neurodegenerative pathologies and psychiatric pathologies with cognitive expression(Up to 10 years)

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