Alzheimer DiseaseADKITNCT07294586
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
An observational study of Alzheimer Disease and Dementia, run by Amoneta Diagnostics SAS at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Neurodegenerative Disorders
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2019to 24 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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)
- Keywords
- Alzehimer's Disease, Blood Biomarkers, Protein Kinase C (PKC), Amyloid Beta, Neurodegeneration, Early Diagnosis, AD Patients
- Medical subject headings
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Dysfunction, Memory Disorders, Plaque, Amyloid, Nerve Degeneration, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (Visit 0)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Throughout the 24-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start28 Oct 2019
- Primary completion28 Oct 2019
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amoneta Diagnostics SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hopitaux Civils de Colmar
- Responsible party
- Sponsor
- Investigators
- François Sellal, MD, Principal investigator, Hopitaux Civils de Colmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294586
- Sponsor's protocol ID
- 2015-AMDx.001
- Other IDs
- 2015-A00118-41
- Acronym
- ADKIT
- Status last verified
- Oct 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07294586
- Acronym / sponsor ID
- ADKIT / 2015-AMDx.001
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Disorders, Cognitive Decline, Memory Loss, Mild Cognitive Impairment (MCI)
- Keywords
- Alzehimer's Disease, Blood Biomarkers, Protein Kinase C (PKC), Amyloid Beta, Neurodegeneration, Early Diagnosis, AD Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Amoneta Diagnostics SASIndustry (pharma, biotech, devices)
- Collaborators
- Hopitaux Civils de Colmar
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects
Time frame: 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.
2 secondary outcomes
Analytical Performance of Biomarkers Across Demographic and Clinical Variables
Time frame: Within 1 month after sample collection
Establishment of a Biobank for Future Biomarker Research
Time frame: Throughout the 24-month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Sellal, MD principal investigator
Hopitaux Civils de Colmar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Amoneta Diagnostics SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects (time frame: At baseline (Visit 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.