Evaluation of a Plasma Marker (p-Tau217) for the Biological Diagnosis of Alzheimer's Disease, and Comparison With CSF Markers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood withdrawal.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease, Biomarkers, Non-invasive Diagnosis, Phosphorylated Protein p-tau217. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other blood withdrawal
blood withdrawal
Primary outcome measures
- plasma p-Tau217 concentration [Time frame: day 1]
Secondary outcome measures (1)
- concordance of plasma-pTau217 with CSF biomarkers [Time frame: day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHRU Amiens — Amiens
Identifiers
NCT: NCT07071649 · PI2024_843_0128