Blood p‑Tau217 test to help diagnose Alzheimer's disease
Evaluation of a Plasma Marker (p-Tau217) for the Biological Diagnosis of Alzheimer's Disease, and Comparison With CSF Markers
This project will test whether a single blood test measuring p‑Tau217 can diagnose Alzheimer's disease as well as current spinal‑fluid markers in people being evaluated for memory problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT07071649 on ClinicalTrials.gov |
What this trial studies
Researchers will recruit 150 patients at the CHU Amiens memory center over an 18‑month period who are already scheduled for lumbar puncture because of suspected Alzheimer's disease. During the same hospitalization when CSF is collected for standard biomarkers, a single EDTA blood tube will be taken to measure plasma p‑Tau217. Plasma p‑Tau217 performance will be compared with established CSF biomarkers (Aβ1‑40, Aβ1‑42, total tau, p‑Tau181) and with the clinical diagnosis of AD. Analyses will report diagnostic accuracy measures and concordance between plasma and CSF results.
Who should consider this trial
Good fit: Adults seen at the CHU Amiens memory clinic with clinical suspicion of Alzheimer's disease who are already being offered lumbar puncture for CSF biomarker testing are ideal candidates.
Not a fit: People without clinical suspicion of Alzheimer's disease, minors, pregnant women, and those under legal guardianship are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, a validated blood p‑Tau217 test could provide a much less invasive and more accessible way to support the biological diagnosis of Alzheimer's disease.
How similar studies have performed: Recent studies have shown plasma p‑Tau217 correlates well with CSF and PET markers and can distinguish Alzheimer's disease from other causes of cognitive decline, supporting this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens
- CHRU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Pia-Manuela Rusu, MD
- Email: rusu.pia-manuela@chu-amiens.fr
- Phone: 33+322087015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.