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RecruitingNCT04844060AnalzheimerUpdated Apr 27, 2023

Cerebro Spinal Fluid Collection (CSF)

An observational study in Alzheimer Disease, Dementia With Lewy Bodies and Frontotemporal Dementia, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Started Feb 2010; still recruiting 16 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
10,000
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • CSF library
  • Database of patients with cognitive disorders
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with cognitive disorders observed at the memory center of Strasbourg and in whom a lumbar puncture is performed as part of the patient's diagnosis.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who do not have a lumbar puncture
  • Patients for whom no accurate diagnostic information is available
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with cognitive impairment

    All patients with cognitive disorders observed at the memory center of Strasbourg and in whom a lumbar puncture is performed as part of the patient's diagnosis.

    Other: Lumbar punction

Interventions

  • OtherLumbar punction

    Lumbar punction

06

What researchers measure

Primary outcomes

  1. CSF collection

    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.

    Time frame: 1 year

Secondary outcomes

  1. Setting up in new study/collaboration

    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.

    Time frame: 1 year

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

07

Study locations

1 of 1 sites recruiting
  • 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
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04844060
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Apr 14, 2021
Start date
Feb 2010
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Apr 27, 2023

Study contacts

Frédéric BLANC, MD/PhD
Contact
frederic.blanc@unistra.fr
33388155858
Olivier BOUSIGES, PharmD/PhD
Contact
olivier.bousiges@chru-strasbourg.fr
33388128909 / 33368854039
Frédéric BLANC, MD/PhD
principal investigator · Hôpitaux Universitaires de Strasbourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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