Alzheimer Blood Biomarkers
Conditions
Brief summary
.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are: * to define a threshold value for each of the plasma, * to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia, * to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes * to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.
Interventions
DIAGNOSTIC_TESTBlood ponction
Blood ponction
Sponsors
Thérèse Jonveaux
Laure Joly
Lucie Hopes
Maia Simon
Franck Schreiner
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man or woman aged 18 or over * Person affiliated to a social security scheme or beneficiary of such a scheme * Person who has received full information on the organization of the research and has signed an informed consent form * Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease
Exclusion criteria
* Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * An adult unable to give consent * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care under articles L. 3212-1 and L. 3213-1. * Pregnant, parturient or breast-feeding women * Persons staying in a health or social establishment for purposes other than research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aβ40 and Aβ42, P-Tau, Tau and NFL | 2 years | Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity/specificity | 2 years | sensitivity, specificity, positive predictive value and negative predictive value of the plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL) according to the defined threshold value, with reference to the A/T/N classification |
| Co-mobidity | 2 years | results of assays for plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL) in subgroups of patients with co-morbidities (notably dyslipidemia, diabetes) |
| Final diagnosis | 2 years | final diagnosis selected according to criteria used in clinical practice (based on a multidisciplinary approach including analysis of biological results) and measurement of plasma biomarkers (Aβ40 and Aβ42, P-Tau and NFL) in the subgroup of patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) |
Countries
France
Contacts
Primary Contactcatherine Malaplate, PhD,PharmD
Backup ContactThérèse Jonveaux, PhD, MD
Outcome results
None listed