Biological Collection of Neurocognitive Disorders

NCT ID: NCT06244875

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2044-02-01

Brief Summary

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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

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Conditions

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Neurocognitive Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients followed in the memory clinic

Sampling

Intervention Type OTHER

Blood and cerebrospinal fluid sampling during the diagnostic visit

Interventions

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Sampling

Blood and cerebrospinal fluid sampling during the diagnostic visit

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Claire Paquet, Pr

Role: CONTACT

33140054313

Jérôme Lambert, Pr

Role: CONTACT

+33142499742

Other Identifiers

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APHP230999

Identifier Type: -

Identifier Source: org_study_id

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