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Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease | Clinical Trials | Clareo Health

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Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease

NCT07294586•Amoneta Diagnostics SAS

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.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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)
+6 more criteria

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 cardiovascular disease
•Current participation in another interventional clinical trial
•Known blood disorders or conditions affecting red blood cell morphology or function
•Recent blood transfusion (within 3 months)
•Substance abuse or alcohol dependence
•Inability to comply with study procedures
+8 more criteria

Locations (1)

Hôpitaux Civils de Colmar

Colmar, Alsace, France

Key Dates

Start Date

October 28, 2019

Primary Completion Date

October 28, 2019

Completion Date

June 24, 2021

Last Updated

December 19, 2025

Enrollment

200

ACTUAL participants

Conditions

Alzheimer DiseaseDementiaNeurodegenerative DisordersCognitive DeclineMemory LossMild Cognitive Impairment (MCI)Early Onset Alzheimer DiseaseLate Onset Alzheimer Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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