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NCT Number: NCT04844060

Cerebro Spinal Fluid Collection (CSF)

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'évaluation et Centre Mémoire de Ressources et de Recherche (CM2R), Hôpital de jour Saint François - Pôle de Gériatrie, Hôpitaux Universitaires de Strasbourg, Hôpital de la Robertsau

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Frédéric BLANC, MD/PhD

CONTACT

frédé[email protected]

33388115624

Olivier BOUSIGES, PharmaD/PhD

CONTACT

[email protected]

33388128909

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar punction

Other

Lumbar punction

Primary outcomes

  1. 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

  1. Setting up in new study/collaboration

    Time frame: 1 year

    This database would allow clinical studies and collaborations to be built easily and quickly.

    For example, when setting up a clinical study with the aim of testing the discriminating potential of a biomarker between various cognitive pathologies, we will only use in this database patients for whom the diagnosis is well established. The objective will be to determine whether the biomarker is capable of discriminating between these well-defined populations.

Other outcomes

  1. To compare the levels of CSF Alzheimer's biomarkers between these different populations and determine their ability to discriminate between AD and other neurodegenerative cognitive pathologies

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric BLANC, MD/PhD

CONTACT

[email protected]

33388155858

Olivier BOUSIGES, PharmD/PhD

CONTACT

[email protected]

33388128909 / 33368854039

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: Analzheimer

Important dates

Study start
2010
Primary completion
2030
Study completion
2030
First posted
Apr 14, 2021
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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