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NCT07071649Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Jan 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
8 Jul 2025
Start date
20 Nov 2025
Primary completion date
Feb 2027
Lead sponsor
Centre Hospitalier Universitaire, Amiens
NCT number
NCT07071649

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 20 Nov 2025 to the primary completion date, Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Minor patients
  • pregnant women
  • patients under guardianship

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHRU Amiens
Coordinator of this site? Confirm its status
AmiensFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.