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Not yet recruiting NCT06304129

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

No phase Interventional Alzheimer Blood Biomarkers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood ponction.
Who it may be relevant to
Registry conditions: Alzheimer Blood Biomarkers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

.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.

Interventions

  • Diagnostic test Blood ponction
    Blood ponction

Primary outcome measures

  • Aβ40 and Aβ42, P-Tau, Tau and NFL [Time frame: 2 years]
Secondary outcome measures (3)
  • Sensitivity/specificity [Time frame: 2 years]
  • Co-mobidity [Time frame: 2 years]
  • Final diagnosis [Time frame: 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHRU De Nancy — Nancy

Identifiers

NCT: NCT06304129 · 2023-A00709-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗