RecruitingNot ApplicableNCT07071649

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

40 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a blood test measuring a protein called p-Tau217 can accurately diagnose Alzheimer's disease, comparing it to the current gold standard of testing spinal fluid (CSF) for Alzheimer's markers. A blood-based test would be far less invasive than a spinal tap. **You may be eligible if...** - You are an adult seen at a memory clinic with suspected Alzheimer's disease - Your doctor has recommended a lumbar puncture (spinal tap) to test for Alzheimer's biomarkers **You may NOT be eligible if...** - You are a minor (under 18) - You are pregnant - You are under legal guardianship that prevents participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERblood withdrawal

blood withdrawal


Locations(1)

CHRU Amiens

Amiens, France

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NCT07071649


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