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Not yet recruiting NCT06244875

Biological Collection of Neurocognitive Disorders

Observational Neurocognitive Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sampling.
Who it may be relevant to
Registry conditions: Neurocognitive Disorders. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Collection Biologique Des Atteintes Neurocognitives

Overview

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.

Interventions

  • Other Sampling
    Blood and cerebrospinal fluid sampling during the diagnostic visit

Primary outcome measures

  • Identification of new biomarkers for neurodegenerative diseases [Time frame: Up to 10 years]
Secondary outcome measures (3)
  • Description of the level of usual biomarkers by type of dementia [Time frame: Up to 10 years]
  • Evaluation of the relationship between biomarker levels and cognitive evolution measured in routine care [Time frame: Up to 10 years]
  • Comparison of biomarker levels in neurodegenerative pathologies and psychiatric pathologies with cognitive expression [Time frame: Up to 10 years]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06244875 · APHP230999

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗