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

NCT07294586 | Completed

• 2 other identifiers: 2015-AMDx.0012015-A00118-41
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia; Neurodegenerative Disorders; Cognitive Decline; Memory Loss; Mild Cognitive Impairment (MCI); Early Onset Alzheimer Disease; Late Onset Alzheimer Disease

Keywords

Alzehimer's Disease; Blood Biomarkers; Protein Kinase C (PKC); Amyloid Beta; Neurodegeneration; Early Diagnosis; AD Patients

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (Visit 0)

Secondary Outcomes (2)

• Analytical Performance of Biomarkers Across Demographic and Clinical Variables

  Within 1 month after sample collection

• Establishment of a Biobank for Future Biomarker Research

  Throughout the 24-month study period

Study Arms (2)

Group 1 - Healthy volunteers

This group includes cognitively healthy individuals aged 50 to 85 years, with no clinical signs of neurodegenerative disease. Participants will undergo clinical evaluation, routine blood and urine sampling, and neuropsychological testing. Samples will be used to establish baseline biomarker levels and support biobank development. Sample Size: 100 participants

Group 2 - AD patients

This group includes patients aged 50 to 85 years diagnosed with Alzheimer's disease based on clinical criteria, neuropsychological testing, and imaging. Participants will undergo comprehensive clinical evaluation and biological sampling to assess biomarker performance. Sample Size: 100 participants

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 200 individuals aged 50 to 85 years, divided into two cohorts: Healthy Volunteers (HV): 100 cognitively healthy individuals with no history of neurodegenerative disease. These participants will serve as controls for biomarker comparison. Alzheimer's Disease Patients (AD): 100 individuals clinically diagnosed with probable Alzheimer's disease based on neuropsychological testing, clinical evaluation, and imaging. These participants represent the target population for biomarker validation. Participants will be stratified by age and sex to ensure balanced representation across both groups. All subjects must be able to provide informed consent and comply with study procedures, including fasting sample collection and clinical assessments.

You may qualify if:

• 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)

You may not qualify if:

• 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
• Any cognitive complaints or subjective memory loss
• First-degree family history of Alzheimer's disease (optional, depending on stratification strategy)
• Use of psychoactive medications
• Diagnosis of mixed or atypical dementia
• Rapidly progressive cognitive decline suggestive of other pathology

Sponsors & Collaborators

• Hopitaux Civils de Colmar: collaborator
• Amoneta Diagnostics SAS: lead

Study Sites (1)

Hôpitaux Civils de Colmar

Colmar, Alsace, 68024, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, urine, and RNA

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Neurodegenerative Diseases; Cognitive Dysfunction; Memory Disorders; Plaque, Amyloid; Nerve Degeneration; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Pathologic Processes

Study Officials

• François Sellal, MD

  Hopitaux Civils de Colmar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: October 28, 2019
• Primary Completion: October 28, 2019
• Study Completion: June 24, 2021
• Last Updated: December 19, 2025

Record last verified: 2025-10

Locations

FR (1)