Biological Collection of Neurocognitive Disorders

Neurocognitive Disorders Clinical Trial

— BioCogBank  

Official title:

Collection Biologique Des Atteintes Neurocognitives

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244875
• Other study ID #: APHP230999
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2044

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Claire Paquet, Pr
• Phone: 33140054313
• Email: claire.paquet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: February 1, 2044
• Est. primary completion date: February 1, 2044
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Neurocognitive Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of new biomarkers for neurodegenerative diseases		Up to 10 years
Secondary	Description of the level of usual biomarkers by type of dementia		Up to 10 years
Secondary	Evaluation of the relationship between biomarker levels and cognitive evolution measured in routine care		Up to 10 years
Secondary	Comparison of biomarker levels in neurodegenerative pathologies and psychiatric pathologies with cognitive expression		Up to 10 years