Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease (NCT07294586) | Clinical Trial Compass
CompletedNot Applicable
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
France200 participantsStarted 2019-10-28
Plain-language summary
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.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion Criteria:
For All Participants (HV and AD groups):
* Age between 50 and 85 years
* Ability to understand and sign informed consent
* Availability for the full duration of the study (24 months)
* Fasting capability for morning sample collection (between 8:30-12:00)
* Willingness to provide blood and urine samples for biomarker analysis and biobank storage
Additional Criteria for Healthy Volunteers (HV):
* No history or current diagnosis of neurodegenerative disease
* Normal cognitive function confirmed by neuropsychological testing (e.g., MMSE score within normal range)
* No significant abnormalities on brain imaging (CT or MRI if performed)
* No use of medications affecting cognitive function
Additional Criteria for Alzheimer's Disease Patients (AD):
* Clinical diagnosis of probable Alzheimer's disease based on standardized criteria
* Cognitive impairment confirmed by neuropsychological testing (e.g., MMSE score below threshold)
* Supporting evidence from brain imaging (CT or MRI) and/or cerebrospinal fluid biomarkers (if available)
* Stable medical condition allowing participation in study procedures
Exclusion Criteria:
For All Participants:
* History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
* Significant neurological conditions other than Alzheimer's disease (e.g., Parkinson's disease, stroke)
* Active malignancy or history of cancer within the past 5 years (except localized skin cancer)
* Severe renal, hepatic, or cardiovasc…
What they're measuring
1
Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects