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

Amoneta Diagnostics

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07294586

2015-AMDx.001

2015-A00118-41 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

200 participants in 2 patient groups

Group 1 - Healthy volunteers

Description:

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

Description:

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