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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07294586

Acronym

ADKIT

Enrollment

200

Registered

2025-12-19

Start date

2019-10-28

Completion date

2021-06-24

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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) * 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)

Design outcomes

Primary

Measure	Time frame	Description
Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects	At baseline (Visit 0)	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.

Secondary

Measure	Time frame	Description
Analytical Performance of Biomarkers Across Demographic and Clinical Variables	Within 1 month after sample collection	Evaluation of the influence of age, sex, sample matrix (serum, plasma, urine), and storage conditions on the analytical performance of each biomarker.
Establishment of a Biobank for Future Biomarker Research	Throughout the 24-month study period	Collection and storage of biological samples (serum, plasma, urine, RNA) from all participants to support future studies on Alzheimer's disease and related biomarkers.

Countries

France

Outcome results