Cerebro Spinal Fluid Collection (CSF) (Analzheimer)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Multiple System Atrophy; Frontotemporal Dementia; Dementia With Lewy Bodies; Parkinson's Disease Dementia
• Intervention / Treatment: Other: Lumbar punction

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Frédéric BLANC, MD/PhD; Phone Number: 33388155858; Email: frederic.blanc@unistra.fr
• Study Contact Backup: Name: Olivier BOUSIGES, PharmD/PhD; Phone Number: 33388128909 / 33368854039; Email: olivier.bousiges@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • 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
    • Contact: Frédéric BLANC, MD/PhD; Phone Number: 33388115624; Email: frédéric.blanc@chru-strasbourg.fr
    • Contact: Olivier BOUSIGES, PharmaD/PhD; Phone Number: 33388128909; Email: olivier.bousiges@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Lumbar punction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Time 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 pathologies	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Frédéric BLANC, MD/PhD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: CSF library; Database of patients with cognitive disorders
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Autonomic Nervous System Diseases; Language Disorders; Communication Disorders; Speech Disorders; Primary Dysautonomias; Hypotension; Frontotemporal Lobar Degeneration; Aphasia; Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease; Multiple System Atrophy; Shy-Drager Syndrome; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: DC-2009-1002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No