Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers (PLASM-ALZ)

March 5, 2024 updated by: Catherine MALAPLATE, Central Hospital, Nancy, France

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

.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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Grand Est
      • Nancy, Grand Est, France, 54500
        • CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood ponction
All patients are in the experimental group
Diagnostic test: Blood ponction
Blood ponction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aβ40 and Aβ42, P-Tau, Tau and NFL
Time Frame: 2 years
Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity/specificity
Time Frame: 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
2 years
Co-mobidity
Time Frame: 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)
2 years
Final diagnosis
Time Frame: 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-)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Thérèse Jonveaux
Laure Joly
Lucie Hopes
Maia Simon
Franck Schreiner

Investigators

  • Principal Investigator: Catherine Malaplate, PhD, PharmD, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2024

Primary Completion (Estimated)

January 2, 2026

Study Completion (Estimated)

September 2, 2026

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A00709-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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