Biological Collection of Neurocognitive Disorders

NCT06244875 | Not Yet Recruiting

• 1 other identifier: APHP230999
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• Identification of new biomarkers for neurodegenerative diseases

  Up to 10 years

Secondary Outcomes (3)

• 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

Study Arms (1)

Patients followed in the memory clinic

Other: Sampling

Interventions

Sampling OTHER

Blood and cerebrospinal fluid sampling during the diagnostic visit

Patients followed in the memory clinic

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in the memory clinic at the Center for Cognitive Neurology of Lariboisière Hospital (APHP) or at the memory clinic of Bretonneau Hospital (APHP), with a clinical indication for the measurement of blood and cerebrospinal fluid (CSF) biomarkers (day hospital for the diagnosis of a neurocognitive disorder).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Claire Paquet, Pr

CONTACT

33140054313; claire.paquet@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2044
• Study Completion (Estimated): February 1, 2044
• Last Updated: February 6, 2024

Record last verified: 2023-12