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

NCT ID: NCT06304129

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2026-09-02

Brief Summary

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.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

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Conditions

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Alzheimer Blood Biomarkers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood ponction

All patients are in the experimental group

Group Type EXPERIMENTAL

Blood ponction

Intervention Type DIAGNOSTIC_TEST

Blood ponction

Interventions

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Blood ponction

Blood ponction

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thérèse Jonveaux

UNKNOWN

Sponsor Role collaborator

Laure Joly

UNKNOWN

Sponsor Role collaborator

Lucie Hopes

UNKNOWN

Sponsor Role collaborator

Maia Simon

UNKNOWN

Sponsor Role collaborator

Franck Schreiner

UNKNOWN

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Catherine MALAPLATE

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Malaplate, PhD, PharmD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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CHRU De Nancy

Nancy, Grand Est, France

Site Status

Countries

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France

Central Contacts

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catherine Malaplate, PhD,PharmD

Role: CONTACT

+33383855511

Thérèse Jonveaux, PhD, MD

Role: CONTACT

Other Identifiers

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2023-A00709-36

Identifier Type: -

Identifier Source: org_study_id

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