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Cerebro Spinal Fluid Collection (CSF)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04844060
Acronym
Analzheimer
Enrollment
10000
Registered
2021-04-14
Start date
2010-02-28
Completion date
2030-12-31
Last updated
2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Multiple System Atrophy, Parkinson's Disease Dementia

Keywords

CSF library, Database of patients with cognitive disorders

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.

Interventions

Lumbar punction

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CSF collection1 yearTo 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

MeasureTime frameDescription
Setting up in new study/collaboration1 yearThis 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

MeasureTime frame
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 pathologies1 year

Countries

France

Contacts

Primary ContactFrédéric BLANC, MD/PhD
frederic.blanc@unistra.fr33388155858
Backup ContactOlivier BOUSIGES, PharmD/PhD
olivier.bousiges@chru-strasbourg.fr33388128909 / 33368854039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026