Cerebro Spinal Fluid Collection (CSF)

Alzheimer Disease Clinical Trial

— Analzheimer  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844060
• Other study ID #: DC-2009-1002
• Status: Recruiting
• Start date: February 2010
• Est. completion date: December 2030

Study information

• Verified date: April 2023
• Source: University Hospital, Strasbourg, France
• Contact: Frédéric BLANC, MD/PhD
• Phone: 33388155858
• Email: frederic.blanc[@]unistra.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Dementia With Lewy Bodies
• Frontotemporal Dementia
• Lewy Body Disease
• Multiple System Atrophy
• Parkinson Disease
• Parkinson's Disease Dementia
• Pick Disease of the Brain
• Shy-Drager Syndrome

Intervention

Other:
• Lumbar punction
Lumbar punction

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		1 year
Primary	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.	1 year
Secondary	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.	1 year