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

NCT06304129 | Not Yet Recruiting

• 1 other identifier: 2023-A00709-36
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Blood Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Sensitivity/specificity

  2 years

• Co-mobidity

  2 years

• Final diagnosis

  2 years

Study Arms (1)

Blood ponction

EXPERIMENTAL

All patients are in the experimental group

Diagnostic Test: Blood ponction

Interventions

Blood ponction DIAGNOSTIC_TEST

Blood ponction

Blood ponction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Thérèse Jonveaux: collaborator
• Laure Joly: collaborator
• Lucie Hopes: collaborator
• Maia Simon: collaborator
• Franck Schreiner: collaborator

Study Sites (1)

CHRU De Nancy

Nancy, Grand Est, 54500, France

Location

Study Officials

• Catherine Malaplate, PhD, PharmD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

catherine Malaplate, PhD,PharmD

CONTACT

+33383855511; c.malaplate@chru-nancy.fr

Thérèse Jonveaux, PhD, MD

CONTACT

t.jonveaux@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 2, 2024
• Primary Completion: January 2, 2026
• Study Completion (Estimated): September 2, 2026
• Last Updated: March 12, 2024

Record last verified: 2023-09

Locations

FR (1)