Biological Collection of Neurocognitive Disorders (BioCogBank)

January 29, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Collection Biologique Des Atteintes Neurocognitives

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients followed in the memory clinic
Other: Sampling
Blood and cerebrospinal fluid sampling during the diagnostic visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of new biomarkers for neurodegenerative diseases
Time Frame: Up to 10 years
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of the level of usual biomarkers by type of dementia
Time Frame: Up to 10 years
Up to 10 years
Evaluation of the relationship between biomarker levels and cognitive evolution measured in routine care
Time Frame: Up to 10 years
Up to 10 years
Comparison of biomarker levels in neurodegenerative pathologies and psychiatric pathologies with cognitive expression
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2044

Study Completion (Estimated)

February 1, 2044

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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