Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Blood ponction

    Diagnostic test

    Blood ponction

Treatment groups

189 Participants
are divided into 1 treatment group
Group A: Blood ponctionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

1

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

Time frame
2 years
2

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)

Time frame
2 years
3

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-)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: