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

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Blood Biomarkers

• Registration Number: NCT06304129
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

.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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-04-02
• Primary Completion: 2026-01-02
• Study Completion: 2026-09-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 189

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Aβ40 and Aβ42, P-Tau, Tau and NFL	2 years	Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF

Secondary Outcome Measures

Name	Time	Method
Final diagnosis	2 years	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-)
Sensitivity/specificity	2 years	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	2 years	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)

Trial Locations

Locations (1)

CHRU De Nancy; 🇫🇷 Nancy, Grand Est, France