About this trial
.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:
* to define a threshold value for each of the plasma, * to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia, * to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes * to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Man or woman aged 18 or over
Person affiliated to a social security scheme or beneficiary of such a scheme
Person who has received full information on the organization of the research and has signed an informed consent form
Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease
Disqualifiers
Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
An adult unable to give consent
Persons deprived of their liberty by judicial or administrative decision
Persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
Trial design
Single group
Treatments tested in this trial
Blood ponction
Diagnostic testBlood ponction
Treatment groups
Trial outcomes
Primary outcomes
Aβ40 and Aβ42, P-Tau, Tau and NFL
Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF
Secondary outcomes
Sensitivity/specificity
sensitivity, specificity, positive predictive value and negative predictive value of the plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL) according to the defined threshold value, with reference to the A/T/N classification
Co-mobidity
results of assays for plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL) in subgroups of patients with co-morbidities (notably dyslipidemia, diabetes)
Final diagnosis
final diagnosis selected according to criteria used in clinical practice (based on a multidisciplinary approach including analysis of biological results) and measurement of plasma biomarkers (Aβ40 and Aβ42, P-Tau and NFL) in the subgroup of patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-)
Sponsors and contacts
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Central Hospital, Nancy, France
Lead sponsor
Thérèse Jonveaux
Collaborator
Laure Joly
Collaborator
Lucie Hopes
Collaborator
Maia Simon
Collaborator
Franck Schreiner
Collaborator
This trial is not recruiting at the moment. You can still explore other options: