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

C

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Alzheimer Blood Biomarkers

Treatments

Diagnostic Test: Blood ponction

Study type

Interventional

Funder types

Other

Identifiers

NCT06304129
2023-A00709-36

Details and patient eligibility

About

.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.

Enrollment

189 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

189 participants in 1 patient group

Blood ponction
Experimental group
Description:
All patients are in the experimental group
Treatment:
Diagnostic Test: Blood ponction

Trial contacts and locations

1

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Central trial contact

catherine Malaplate, PhD,PharmD; Thérèse Jonveaux, PhD, MD

Data sourced from clinicaltrials.gov

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