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

N/ANot Yet RecruitingNCT06304129

Central Hospital, Nancy, France189 enrolled

Overview

.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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

189

Conditions

Alzheimer Blood Biomarkers

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Pregnant, parturient or breast-feeding women * Persons staying in a health or social establishment for purposes other than research.

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

Time frame: 2 years

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

Time frame: 2 years

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts