ClinicalTrials.gov record NCT04844060

Cerebro Spinal Fluid Collection (CSF)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Apr 27, 2023, about 3 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study gathers cerebrospinal fluid (CSF) and clinical data from people with cognitive disorders who have a lumbar puncture as part of their diagnostic work-up. The project creates a linked database of CSF Alzheimer's biomarkers, neuropsychological tests, clinical exams, and brain imaging. The database will be used to describe which diagnoses led clinicians to order CSF biomarker testing.

What it is studying. Whether routinely used Alzheimer's CSF biomarkers appear in people with different neurodegenerative cognitive diseases, and to build a combined clinical and CSF database to support diagnosis-related research.

What the researchers hope to learn. Create a clinical and biological database linking CSF Alzheimer's biomarkers with diagnoses, tests, and imaging. Estimate how often different diagnoses prompt CSF biomarker testing. Provide a resource to support future studies that test biomarkers' ability to distinguish between cognitive disorders.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Lumbar punction

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have cerebrospinal fluid (CSF) collected via lumbar puncture (spinal tap) and the CSF will be used to measure Alzheimer's biomarkers and entered into a study database. The study will also record clinical information such as neuropsychological test results, clinical examinations, brain imaging results (for example MRI, PET‑FDG, DAT‑SCAN), and the clinician's final diagnosis. Participation involves allowing these samples and clinical and diagnostic data to be included in the database. The registry record does not specify additional study treatments, visits, or follow-up beyond the CSF and data collection.

How the study is structured. Single-group observational cohort. People who undergo a lumbar puncture for clinical diagnosis provide CSF and related clinical information. The study collects and stores CSF biomarker results alongside clinical notes, neuropsychological test results, and imaging reports for analysis; no experimental treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
February 2010
Primary completion
December 2030 (estimated)
Study completion
December 2030 (estimated)
Target enrollment
10000 participants (estimated)
Last updated on registry
Apr 27, 2023
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital, Strasbourg, France

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
lumbar puncture
A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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