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Clinical Trials/NCT07071649
NCT07071649RecruitingNot Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country40 target enrollmentStarted: November 20, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
plasma p-Tau217 concentration

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • concordance of plasma-pTau217 with CSF biomarkers(day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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