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

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 Overview

• Status: Completed
• Conditions: Dementia; Mild Cognitive Impairment (MCI); Alzheimer Disease; Cognitive Decline; Neurodegenerative Disorders; Memory Loss; Early Onset Alzheimer Disease; Late Onset Alzheimer Disease

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Alsace
    • Colmar, Alsace, France, 68024
      • Hôpitaux Civils de Colmar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 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

Additional Exclusion for Healthy Volunteers:

• Any cognitive complaints or subjective memory loss
• First-degree family history of Alzheimer's disease (optional, depending on stratification strategy)
• Use of psychoactive medications

Additional Exclusion for Alzheimer's Disease Patients:

• Diagnosis of mixed or atypical dementia
• Rapidly progressive cognitive decline suggestive of other pathology
• Contraindications to lumbar puncture (if CSF sampling is planned)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Throughout the 24-month study period

Collaborators and Investigators

• Sponsor: Amoneta Diagnostics SAS
• Collaborators: Hopitaux Civils de Colmar
• Investigators: Principal Investigator: François Sellal, MD, Hôpitaux Civils de Colmar

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): October 28, 2019
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Neurodegeneration; Early Diagnosis; Blood Biomarkers; Amyloid Beta; Alzehimer's Disease; Protein Kinase C (PKC); AD Patients
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Anatomical; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cognitive Dysfunction; Alzheimer Disease; Disease; Dementia; Neurodegenerative Diseases; Memory Disorders; Plaque, Amyloid; Nerve Degeneration
• Other Study ID Numbers: 2015-AMDx.001; 2015-A00118-41 (Registry Identifier: RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No