Biological Collection of Neurocognitive Disorders

Not yet recruiting

• Conditions: Neurocognitive Disorders
• Interventions: Other: Sampling

• Registration Number: NCT06244875
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study Start: 2024-02-01
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06
• Primary Completion: 2044-02-01
• Study Completion: 2044-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients followed in the memory clinic	Sampling	-

Primary Outcome Measures

Name	Time	Method
Identification of new biomarkers for neurodegenerative diseases	Up to 10 years

Secondary Outcome Measures

Name	Time	Method
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