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NCT Number: NCT06304129

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

.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.

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Key information

Conditions

Alzheimer Blood Biomarkers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU De Nancy

Nancy, Grand Est, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood ponction

Diagnostic Test

Blood ponction

Primary outcomes

  1. Aβ40 and Aβ42, P-Tau, Tau and NFL

    Time frame: 2 years

    Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF

Secondary outcomes

  1. Sensitivity/specificity

    Time frame: 2 years

    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. Co-mobidity

    Time frame: 2 years

    results of assays for plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL) in subgroups of patients with co-morbidities (notably dyslipidemia, diabetes)

  3. Final diagnosis

    Time frame: 2 years

    final diagnosis selected according to criteria used in clinical practice (based on a multidisciplinary approach including analysis of biological results) and measurement of plasma biomarkers (Aβ40 and Aβ42, P-Tau and NFL) in the subgroup of patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-)

Study contacts

Contact information is provided by the study sponsor or research team.

Thérèse Jonveaux, PhD, MD

CONTACT

[email protected]

catherine Malaplate, PhD,PharmD

CONTACT

[email protected]

+33383855511

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Franck Schreiner
  • Laure Joly
  • Lucie Hopes
  • Maia Simon
  • Thérèse Jonveaux

Registry information

Official study title

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

Acronym: PLASM-ALZ

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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