Cerebro Spinal Fluid Collection (CSF)

NCT04844060 | Recruiting

• 1 other identifier: DC-2009-1002
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

CSF library; Database of patients with cognitive disorders

Outcome Measures

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.

  1 year

Secondary Outcomes (1)

• Setting up in new study/collaboration

  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

  1 year

Study Arms (1)

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

Lumbar punction OTHER

Lumbar punction

Patients with cognitive impairment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Frédéric BLANC, MD/PhD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric BLANC, MD/PhD

CONTACT

33388155858; frederic.blanc@unistra.fr

Olivier BOUSIGES, PharmD/PhD

CONTACT

33388128909 / 33368854039; olivier.bousiges@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 14, 2021
• Study Start: February 1, 2010
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)