Validation of blood biomarkers for Alzheimer's disease
Clinical Validation of the Use of Blood Biomarkers for the Diagnosis and Monitoring of Alzheimer's Disease
NA · University Hospital, Montpellier · NCT05427448
This study is testing whether certain blood tests can help doctors diagnose Alzheimer's disease more accurately by comparing them to traditional tests done on spinal fluid.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 3 sites (Montpellier, Occitanie and 2 other locations) |
| Trial ID | NCT05427448 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the diagnostic performance of blood biomarkers for Alzheimer's disease (AD) through a prospective clinical trial. It focuses on measuring amyloid peptides, tau proteins, and neurofilaments in blood samples from patients consulting at memory clinics. The study will compare these blood biomarkers with cerebrospinal fluid (CSF) analysis to assess their effectiveness in diagnosing AD and related conditions. The goal is to improve the stratification of patients and enhance diagnostic accuracy in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are consulting at memory clinics and have undergone CSF AD biomarker testing.
Not a fit: Patients who refuse lumbar puncture or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less invasive and more accessible method for diagnosing Alzheimer's disease.
How similar studies have performed: Other studies have shown promise in using blood biomarkers for Alzheimer's diagnosis, but this approach is still being validated in a prospective setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan. * Age \>= 18 years old * CSF AD biomarkers performed for diagnostic purpose in clinical routine practice * Having given their written and enlightened consent * Affiliated or beneficiary of the national health insurance Exclusion Criteria: * Contraindication or refusal of lumbar puncture * Patient deprived of freedom, by court or administrative order, or major protected by law * Pregnant or breastfeeding women
Where this trial is running
Montpellier, Occitanie and 2 other locations
- Montpellier University Hospital — Montpellier, Occitanie, France (RECRUITING)
- Nîmes University Hospital — Nîmes, Occitanie, France (RECRUITING)
- Perpignan Regional Hospital — Perpignan, Occitanie, France (RECRUITING)
Study contacts
- Principal investigator: Sylvain Lehmann, MD PhD — University Hospital, Montpellier
- Study coordinator: Sylvain Lehmann, MD PhD
- Email: s-lehmann@chu-montpellier.fr
- Phone: 0467337123
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.
Conditions: Alzheimer Disease, Mild Cognitive Impairment, Dementia, Tauopathies, blood, Alzheimer, biomarker