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NCT Number: NCT07071649

Evaluation of a Plasma Marker (p-Tau217) for the Biological Diagnosis of Alzheimer's Disease, and Comparison With CSF Markers

The biological diagnosis of AD is actually performed by analysing Aβ1-40 and Aβ1-42 peptides, total tau and tau phosphorylated at Thr181 (p-Tau181) from cerebrospinal fluid (CSF) samples obtained by lumbar puncture (LP). Phospho-Tau 217 (p-Tau217) is a new biomarker that could be measured in plasma. The aim of this study is to compare the performances of plasma p-Tau217 with those of the reference CSF biomarkers in 150 patients recruited in the memory center of CHU Amiens (France). The study will be conducted during 18 months. The inclusion will be proposed to all patients for whom an indication of lumbar puncture / CSF is raised in a context of clinical suspicion of AD. During the daily hospitalization during which CSF will be collected for the "classical" biomarkers testing, a single tube of blood will be collected (anticoagulant EDTA, collected for p-Tau 217 analysis). The performances of CSF and plasma pTau 217 will be compared with the clinical diagnosis of AD (+, -, or indeterminate).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, 80090, France

Location status: Recruiting

Location contact

Pia-Manuela Rusu, MD

CONTACT

[email protected]

33+322087015

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients addressed to the memory center of CHU Amiens with a clinical suspicion of AD, for whom lumbar puncture / CSF biomarkers of AD determination is proposed.

Exclusion criteria

  • Minor patients
  • pregnant women
  • patients under guardianship

Treatment and study plan

blood withdrawal

Other

blood withdrawal

Primary outcomes

  1. plasma p-Tau217 concentration

    Time frame: day 1

    Analysis of performances of plasma p-Tau217 for the diagnosis of AD by using the kit supplier references.

Secondary outcomes

  1. concordance of plasma-pTau217 with CSF biomarkers

    Time frame: day 1

    Comparison of plasma-pTau217 with CSF biomarkers, realization of a concordance matrix.

Study contacts

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

Pia-Manuela Rusu, MD

CONTACT

[email protected]

33+322087015

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ALZBIOSANG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Jan 16, 2026

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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