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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07071649

Acronym

ALZBIOSANG

Enrollment

Registered

2025-07-17

Start date

2025-11-20

Completion date

2027-02-01

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Biomarkers, Non-invasive Diagnosis, Phosphorylated Protein p-tau217

Keywords

Alzheimer's Disease, Biomarkers, Non-invasive diagnosis, Phosphorylated protein p-tau217

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).

Interventions

OTHERblood withdrawal

blood withdrawal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
plasma p-Tau217 concentration	day 1	Analysis of performances of plasma p-Tau217 for the diagnosis of AD by using the kit supplier references.

Secondary

Measure	Time frame	Description
concordance of plasma-pTau217 with CSF biomarkers	day 1	Comparison of plasma-pTau217 with CSF biomarkers, realization of a concordance matrix.

Countries

France

Contacts

CONTACTPia-Manuela Rusu, MD

rusu.pia-manuela@chu-amiens.fr33+322087015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026