This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD). The test is based on two complementary biomarkers: conformational changes in Protein Kinase C (PKC) and aggregation of β-amyloid peptide on red blood cell membranes. The study will also establish a biobank of serum, plasma, urine, and RNA samples for future biomarker research.
Study Type
OBSERVATIONAL
Enrollment
200
Hôpitaux Civils de Colmar
Colmar, Alsace, France
Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects
Measurement and comparison of two blood-based biomarkers-(1) conformational change in Protein Kinase C (PKC) and (2) aggregation of β-amyloid peptide (Aβ1-42) on red blood cell membranes-between patients diagnosed with Alzheimer's disease and age- and sex-matched healthy volunteers. The goal is to assess the diagnostic performance of each biomarker individually.
Time frame: At baseline (Visit 0)
Analytical Performance of Biomarkers Across Demographic and Clinical Variables
Evaluation of the influence of age, sex, sample matrix (serum, plasma, urine), and storage conditions on the analytical performance of each biomarker.
Time frame: Within 1 month after sample collection
Establishment of a Biobank for Future Biomarker Research
Collection and storage of biological samples (serum, plasma, urine, RNA) from all participants to support future studies on Alzheimer's disease and related biomarkers.
Time frame: Throughout the 24-month study period
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