Diagnostic Performance of Plasma Biomarkers of Alzheimer'... | NCT06304129

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

NCT06304129

Sponsor

Central Hospital, Nancy, France

Status

Not yet recruiting

Last Update Posted

Mar 12, 2024Actual

Enrollment

189Estimated

Phase

Not Applicable

Conditions

Alzheimer Blood Biomarkers

Interventions

Blood ponction

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2024Estimated

Primary Completion Date

Jan 2, 2026Estimated

Completion Date

Sep 2, 2026Estimated

First Submitted Date

Mar 5, 2024

First Submission Date that Met QC Criteria

Mar 5, 2024

First Posted Date

Mar 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Catherine MALAPLATE, Dr, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Name	Class
Thérèse Jonveaux	UNKNOWN
Laure Joly	UNKNOWN
Lucie Hopes	UNKNOWN
Maia Simon

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

189Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood ponction	Experimental	All patients are in the experimental group	Diagnostic Test: Blood ponction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood ponction	Diagnostic Test	Blood ponction	Blood ponction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	2 years

Secondary Outcomes

Measure	Description	Time Frame
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	2 years
Co-mobidity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
catherine Malaplate, PhD,PharmD	Contact	+33383855511		c.malaplate@chru-nancy.fr
Thérèse Jonveaux, PhD, MD	Contact			t.jonveaux@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
Catherine Malaplate, PhD, PharmD	CHRU Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU De Nancy		Nancy	Grand Est	54500	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided