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Clinical Trials/NCT04844060
NCT04844060
Recruiting
N/A

Analysis of Clinical Data and Diagnosis in Any Person Requiring an Assay of Alzheimer Biomarkers in Cerebrospinal Fluid

University Hospital, Strasbourg, France1 site in 1 country10,000 target enrollmentFebruary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University Hospital, Strasbourg, France
Enrollment
10000
Locations
1
Primary Endpoint
CSF collection
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Cognitive neurodegenerative diseases are a major public health issue. At present, the diagnosis of certainty is still based on anatomopathological analyses. Even if the diagnostic tools available to clinicians have made it possible to improve probabilistic diagnosis during the patient's lifetime, there are still too many diagnostic errors and sub-diagnostic in this field. The arrival of biomarkers has made it possible to reduce these diagnostic errors, which were of the order of 25 to 30%. This high error rate is due to different parameters. These diseases are numerous and often present common symptoms due to the fact that common brain structures are affected. These diseases evolve progressively over several years and their early diagnosis, when the symptoms are discrete, makes them even more difficult to diagnose at this stage. In addition, co-morbidities are common in the elderly, further complicating the diagnosis of these diseases.

At present, the only cerebrospinal fluid (CSF) biomarkers that are routinely used for the biological diagnosis of neurodegenerative cognitive pathologies are those specific to Alzheimer's disease: Aβ42, Aβ40, Tau-total and Phospho-Tau. These biomarkers represent an almost indispensable tool in the diagnosis of dementia.

It is therefore important to determine whether Alzheimer's biomarkers can be disrupted in other neurodegenerative cognitive pathologies, but also to find biomarkers specific to these different pathologies by facilitating the implementation of clinical studies which will thus make it possible to improve their diagnosis.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
December 2030
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with lumbar puncture (LP)
  • Patients with accurate clinical diagnosis

Exclusion Criteria

  • Patients who do not have a lumbar puncture
  • Patients for whom no accurate diagnostic information is available

Outcomes

Primary Outcomes

CSF collection

Time Frame: 1 year

To create a database of patients with cognitive disorders in whom a lumbar puncture has been carried out in order to measure Alzheimer's biomarkers. This database would not only be biological but also clinical and diagnostic, including the results of neuropsychological tests, clinical examinations, the results of brain imaging (MRI, PET-FDG, DAT-SCAN,...) as well as the last diagnosis retained by the clinician in charge of the patient. Thus, after completing this database, the main objective is to evaluate the proportion of different diseases that have led to the decision to search for Alzheimer biomarkers in CSF.

Secondary Outcomes

  • Setting up in new study/collaboration(1 year)

Study Sites (1)

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