Alzheimer's Disease (AD)ADCHIPNCT07307872
A Biomarker-chip Assay in Preserved Red Blood Cells for the Diagnosis of Alzheimer's Disease
An observational study of Alzheimer's Disease (AD) and Neurodegenerative Disease, run by Amoneta Diagnostics SAS at 1 site in Switzerland.
Trial summary
The ADCHIP study (ST0067) is a non-interventional, monocentric, prospective study conducted by Amoneta Diagnostics and the Leenaards Memory Center (Lausanne, Switzerland). Its main objective is to develop and validate a microfluidic chip-based protocol that stabilizes human red blood cells for several weeks, enabling… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD), Neurodegenerative Disease, Dementia
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Mar 2017to 1 Dec 2018
- 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 150 adults aged 50 to 85 years recruited at the Leenaards Memory Center (CHUV, Lausanne, Switzerland). Participants are divided equally into three groups: * Alzheimer's disease (AD) group: 50 patients diagnosed with Alzheimer's disease according to clinical, neuropsychological, neuroimaging, and CSF biomarker criteria. * Non-Alzheimer neurodegenerative disease (NAD) group: 50 patients with frontotemporal dementia (FTD) or Parkinson's disease (PD) responsive to L-DOPA, negative for AD biomarkers. * Healthy control (HC) group: 50 cognitively normal individuals with normal MRI and neuropsychological profiles. Participants are recruited during routine clinical evaluations or follow-up visits. Healthy controls are recruited through local advertisement within the hospital network. All subjects (or their legal representatives) provide written informed consent prior to participation.
Who may be able to join
- General (all groups):
- Male or female participants aged 50 to 85 years.
- Signed and dated written informed consent (or consent from a legally authorized representative when applicable).
- Alzheimer's Disease (AD) Group:
- Clinical diagnosis of Alzheimer's disease with a gradual and progressive decline in memory over at least 6 months.
- Objective evidence of an amnestic syndrome of the hippocampal type (based on RLRI-16, MoCA, or equivalent tests).
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- Montreal Cognitive Assessment (MoCA) score between 15 and 23 (inclusive).
- Structural MRI compatible with a typical AD diagnosis (3D volumetric MRI required; amyloid PET if available).
- Retrospective CSF biomarker results showing at least 2 of 3 markers positive (Aβ1-42, total Tau, phosphorylated Tau).
- Patients with familial AD forms (mutations in APP, PSEN1, or PSEN2) may also be included.
- Non-Alzheimer Neurodegenerative Disease (NAD) Group:
- 25 patients with frontotemporal dementia (FTD) and 25 patients with Parkinson's disease (PD) responsive to L-DOPA.
- Retrospective CSF biomarker results showing negative or non-AD profiles (≥2 of 3 markers negative).
- Neuroimaging compatible with respective diagnoses:
- FTD: medial temporal atrophy and frontal atrophy score ≥2; MoCA 15-23. PD: evidence of dopaminergic neuron loss in substantia nigra; MoCA >23.
- Healthy Control (HC) Group:
- Normal cognitive status (MoCA >23 and normal performance on RLRI-16 or equivalent neuropsychological tests).
- Normal structural MRI (and normal PET scan, if available).
- Negative CSF biomarkers (if available).
Who cannot join
- General (all groups):
- Neutropenia (neutrophils <1,500/mm³) or thrombocytopenia (platelets <100,000/mm³).
- Education level below primary school.
- History of psychiatric disorders (schizophrenia, psychosis).
- Vascular dementia or mixed dementia.
- Active infectious or chronic inflammatory diseases affecting blood cell function.
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- Active cancer or cancer under treatment, or treatment stopped within the last 3 months.
- Use of medications interfering with cognitive function or biomarkers of interest.
- Major sensory deficits (visual or auditory) affecting cognitive testing.
- Epilepsy.
- Known contraindication to MRI (e.g., stent or metallic implant).
- Group-specific exclusions:
- AD group: Exclude vascular dementia, Lewy body dementia, mixed dementia, or any non-AD neurodegenerative disease.
- NAD group: Exclude Alzheimer's disease, vascular, or mixed dementia.
- HC group: Exclude any neurodegenerative disease, cognitive disorder, or abnormal cognitive testing.
Trial locations and contacts
1 site in 1 country.
About this study
The ADCHIP study (ST0067) is a non-interventional, monocentric, prospective study conducted by Amoneta Diagnostics and the Leenaards Memory Center (Lausanne, Switzerland). Its main objective is to develop and validate a microfluidic chip-based protocol that stabilizes human red blood cells for several weeks, enabling subsequent testing of blood biomarkers for Alzheimer's disease (AD) diagnosis.
This proof-of-performance study will include 150 well-characterized participants divided equally into three groups: 50 patients with Alzheimer's disease (AD), 50 with non-Alzheimer neurodegenerative diseases (NAD, including Parkinson's disease and frontotemporal dementia), and 50 healthy controls (HC).
Read more
The primary objective is to assess the diagnostic performance (sensitivity and specificity) of two main blood-based biomarkers-amyloid-β (Aβ) and protein kinase C (PKC)-measured using Amoneta's proprietary fluorescent assays and chip-cytometry technology. The secondary objective is to evaluate emerging biomarkers (proteins, RNA signatures, metabolomic and lipidomic profiles) for Alzheimer's disease detection.
No therapeutic intervention will be administered; only biological samples (blood and urine) will be collected. Results will be compared with existing clinical, imaging, and cerebrospinal fluid (CSF) biomarkers. The study aims to provide a reliable, non-invasive, and affordable blood test for early Alzheimer's diagnosis, with potential applications for patient stratification and therapeutic monitoring in future clinical trials.
Read the detailed description
Alzheimer's disease (AD) is the most common form of dementia, affecting approximately 35 million people worldwide. While several symptomatic treatments are available, there is currently no cure for advanced forms of AD. Early and accurate diagnosis is therefore essential, as it can help delay disease progression and improve patient management. Current diagnostic tools-clinical and neuropsychological assessments combined with neuroimaging and cerebrospinal fluid (CSF) biomarkers-are costly, invasive, and not easily accessible for large-scale screening. There is a pressing medical need for a simple, non-invasive, and reliable blood-based diagnostic test for AD.
The ADCHIP study (ST0067) aims to develop and validate a chip-based microfluidic assay that stabilizes human red blood cells for extended periods (weeks to months) to enable subsequent detection of blood biomarkers for Alzheimer's disease. The study is conducted under the Eurostars program (Grant E!9748 ADCHIP) and sponsored by Amoneta Diagnostics, in collaboration with Zellkraftwerk GmbH and the Leenaards Memory Center (CLM) at Lausanne University Hospital (CHUV).
This monocentric, non-interventional, prospective study will enroll 150 participants divided equally into three groups:
50 patients with Alzheimer's disease (AD),
50 patients with non-Alzheimer neurodegenerative disorders (NAD: frontotemporal dementia or Parkinson's disease), and
50 healthy controls (HC).
The primary objective is to evaluate the diagnostic performance of two proprietary Amoneta blood biomarkers-amyloid-β (Aβ) and protein kinase C (PKC)-detected in red blood cells using specific fluorescent probes and chip-cytometry technology. The secondary objective is to assess the diagnostic accuracy of emerging biomarkers, including candidate proteins, RNA signatures, and metabolomic/lipidomic profiles.
Participants will undergo a single study visit during which biological samples (blood and urine) will be collected. Pre-selection and diagnostic data (neuropsychological tests, imaging, and CSF biomarkers) will be obtained retrospectively when available. No investigational drug or medical device will be administered, and no follow-up visits are planned. The total duration of subject enrollment is approximately 22 months.
Analytical methods include flow cytometry and chip-cytometry for cellular biomarkers, ELISA for protein biomarkers, mass spectrometry for metabolomic/lipidomic signatures, and qPCR or NGS-based assays for RNA biomarkers. All samples will be collected and stored under standardized conditions for further analysis.
The primary outcome measure is the binary diagnostic classification (Yes/No for Alzheimer's disease) derived from the combined sensitivity and specificity of the blood biomarkers. Results will be compared with standard clinical diagnostic tools, including cognitive scores (e.g., MoCA, RLRI-16), structural MRI, and CSF biomarker results (Aβ42, total tau, phosphorylated tau).
Potential risks for participants are minimal and limited to standard blood and urine collection procedures (e.g., minor pain, bruising, or transient discomfort). MRI procedures are non-invasive and will only be performed if indicated by clinical necessity. All participants (or legal representatives when applicable) will provide written informed consent prior to inclusion. The study complies with the Declaration of Helsinki, ICH-GCP, and national ethical and regulatory requirements.
The ADCHIP study is expected to generate important new knowledge by validating a novel, rapid, and affordable blood-based diagnostic test for Alzheimer's disease. Such a test could substantially reduce diagnostic costs, enable population screening using stabilized blood samples, and improve patient stratification for therapeutic trials. Furthermore, the validated biomarkers, particularly Aβ and PKC, may serve as valuable tools for monitoring disease progression and assessing the efficacy of future AD therapeutics.
- Conditions
- Alzheimer's Disease (AD), Neurodegenerative Disease, Dementia, Frontotemporal Dementia (FTD)
- Keywords
- Blood biomarkers, Alzheimer's disease diagnosis, Amyloid-beta, Protein kinase C (PKC), Microfluidic chip, Chip-cytometry, Red Blood cell stabilization, Non-invasive diagnosis test, Early detection of Alzkeimer's disease
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Dementia, Frontotemporal Dementia, Plaque, Amyloid
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 - Alzheimer's Disease (AD) | Participants meeting clinical and biomarker criteria for Alzheimer's disease, with compatible neuroimaging and/or CSF biomarker profiles. | |
| Group 2 - Non-Alzheimer Neurodegenerative Diseases (NAD) | Participants with frontotemporal dementia (FTD) or Parkinson's disease (PD), negative for AD CSF biomarkers. | |
| Group 3 - Healthy Controls (HC) | Cognitively normal individuals, with normal neuropsychological testing and neuroimaging, and negative (if available) CSF biomarkers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of Aβ and PKC blood biomarkers for Alzheimer's disease detection
Quantitative assessment of the sensitivity and specificity of amyloid-β (Aβ) and protein kinase C (PKC) biomarkers measured in stabilized red blood cells using Amoneta's fluorescent microfluidic chip technology. The diagnostic result will be expressed as a binary outcome (Yes/No for Alzheimer's disease) and compared with standard clinical, neuropsychological, neuroimaging, and CSF diagnostic criteria.
Measured: Immediately after the biological sample collection (single visit per participant).
Secondary outcomes (2)
Diagnostic performance of emerging circulating biomarkers for Alzheimer's disease detection
Evaluation of additional candidate biomarkers (protein markers, RNA signatures, metabolomic and lipidomic profiles) in blood and urine samples. Sensitivity, specificity, and overall diagnostic accuracy will be quantified and compared to established clinical and CSF diagnostic methods.
Measured: Immediately after biological sample collection (single visit per participant).
Comparative analysis between blood-based biomarkers and standard Alzheimer's disease diagnostic tools
Comparison of biomarker-based diagnostic performance (Aβ, PKC, and emerging biomarkers) with conventional diagnostic parameters, including cognitive scores (MoCA, RLRI-16), neuroimaging (MRI and PET), and CSF biomarkers (Aβ42, Tau, p-Tau).
Measured: Immediately after the data analysis following sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start23 Mar 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amoneta Diagnostics SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Leenaards Fondation, Switzerland
- Responsible party
- Sponsor
- Investigators
- Jean-François Démonet, MD, PhD, Principal investigator, Leenaards Memory Center (CLM), Lausanne University Hospital (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307872
- Sponsor's protocol ID
- ST0067
- Other IDs
- 2017-00585, 2017
- Acronym
- ADCHIP
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker-chip Assay in Preserved Red Blood Cells for the Diagnosis of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07307872
- Acronym / sponsor ID
- ADCHIP / ST0067
- Conditions
- Alzheimer's Disease (AD), Neurodegenerative Disease, Dementia, Frontotemporal Dementia (FTD)
- Keywords
- Blood biomarkers, Alzheimer's disease diagnosis, Amyloid-beta, Protein kinase C (PKC), Microfluidic chip, Chip-cytometry, Red Blood cell stabilization, Non-invasive diagnosis test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Amoneta Diagnostics SASIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Leenaards Fondation, Switzerland
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 29 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.
The ADCHIP study (ST0067) is a non-interventional, monocentric, prospective study conducted by Amoneta Diagnostics and the Leenaards Memory Center (Lausanne, Switzerland). Its main objective is to develop and validate a microfluidic chip-based protocol that stabilizes human red blood cells for several weeks, enabling subsequent testing of blood biomarkers for Alzheimer's disease (AD) diagnosis.
This proof-of-performance study will include 150 well-characterized participants divided equally into three groups: 50 patients with Alzheimer's disease (AD), 50 with non-Alzheimer neurodegenerative diseases (NAD, including Parkinson's disease and frontotemporal dementia), and 50 healthy controls (HC).
The primary objective is to assess the diagnostic performance (sensitivity and specificity) of two main blood-based biomarkers-amyloid-β (Aβ) and protein kinase C (PKC)-measured using Amoneta's proprietary fluorescent assays and chip-cytometry technology. The secondary objective is to evaluate emerging biomarkers (proteins, RNA signatures, metabolomic and lipidomic profiles) for Alzheimer's disease detection.
No therapeutic intervention will be administered; only biological samples (blood and urine) will be collected. Results will be compared with existing clinical, imaging, and cerebrospinal fluid (CSF) biomarkers. The study aims to provide a reliable, non-invasive, and affordable blood test for early Alzheimer's diagnosis, with potential applications for patient stratification and therapeutic monitoring in future clinical trials.
Detailed description
Alzheimer's disease (AD) is the most common form of dementia, affecting approximately 35 million people worldwide. While several symptomatic treatments are available, there is currently no cure for advanced forms of AD. Early and accurate diagnosis is therefore essential, as it can help delay disease progression and improve patient management. Current diagnostic tools-clinical and neuropsychological assessments combined with neuroimaging and cerebrospinal fluid (CSF) biomarkers-are costly, invasive, and not easily accessible for large-scale screening. There is a pressing medical need for a simple, non-invasive, and reliable blood-based diagnostic test for AD.
The ADCHIP study (ST0067) aims to develop and validate a chip-based microfluidic assay that stabilizes human red blood cells for extended periods (weeks to months) to enable subsequent detection of blood biomarkers for Alzheimer's disease. The study is conducted under the Eurostars program (Grant E!9748 ADCHIP) and sponsored by Amoneta Diagnostics, in collaboration with Zellkraftwerk GmbH and the Leenaards Memory Center (CLM) at Lausanne University Hospital (CHUV).
This monocentric, non-interventional, prospective study will enroll 150 participants divided equally into three groups:
50 patients with Alzheimer's disease (AD),
50 patients with non-Alzheimer neurodegenerative disorders (NAD: frontotemporal dementia or Parkinson's disease), and
50 healthy controls (HC).
The primary objective is to evaluate the diagnostic performance of two proprietary Amoneta blood biomarkers-amyloid-β (Aβ) and protein kinase C (PKC)-detected in red blood cells using specific fluorescent probes and chip-cytometry technology. The secondary objective is to assess the diagnostic accuracy of emerging biomarkers, including candidate proteins, RNA signatures, and metabolomic/lipidomic profiles.
Participants will undergo a single study visit during which biological samples (blood and urine) will be collected. Pre-selection and diagnostic data (neuropsychological tests, imaging, and CSF biomarkers) will be obtained retrospectively when available. No investigational drug or medical device will be administered, and no follow-up visits are planned. The total duration of subject enrollment is approximately 22 months.
Analytical methods include flow cytometry and chip-cytometry for cellular biomarkers, ELISA for protein biomarkers, mass spectrometry for metabolomic/lipidomic signatures, and qPCR or NGS-based assays for RNA biomarkers. All samples will be collected and stored under standardized conditions for further analysis.
The primary outcome measure is the binary diagnostic classification (Yes/No for Alzheimer's disease) derived from the combined sensitivity and specificity of the blood biomarkers. Results will be compared with standard clinical diagnostic tools, including cognitive scores (e.g., MoCA, RLRI-16), structural MRI, and CSF biomarker results (Aβ42, total tau, phosphorylated tau).
Potential risks for participants are minimal and limited to standard blood and urine collection procedures (e.g., minor pain, bruising, or transient discomfort). MRI procedures are non-invasive and will only be performed if indicated by clinical necessity. All participants (or legal representatives when applicable) will provide written informed consent prior to inclusion. The study complies with the Declaration of Helsinki, ICH-GCP, and national ethical and regulatory requirements.
The ADCHIP study is expected to generate important new knowledge by validating a novel, rapid, and affordable blood-based diagnostic test for Alzheimer's disease. Such a test could substantially reduce diagnostic costs, enable population screening using stabilized blood samples, and improve patient stratification for therapeutic trials. Furthermore, the validated biomarkers, particularly Aβ and PKC, may serve as valuable tools for monitoring disease progression and assessing the efficacy of future AD therapeutics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Alzheimer's Disease (AD) | – | –Participants meeting clinical and biomarker criteria for Alzheimer's disease, with compatible neuroimaging and/or CSF biomarker profiles. |
| Group 2 - Non-Alzheimer Neurodegenerative Diseases (NAD) | – | –Participants with frontotemporal dementia (FTD) or Parkinson's disease (PD), negative for AD CSF biomarkers. |
| Group 3 - Healthy Controls (HC) | – | –Cognitively normal individuals, with normal neuropsychological testing and neuroimaging, and negative (if available) CSF biomarkers. |
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 150 adults aged 50 to 85 years recruited at the Leenaards Memory Center (CHUV, Lausanne, Switzerland). Participants are divided equally into three groups: * Alzheimer's disease (AD) group: 50 patients diagnosed with Alzheimer's disease according to clinical, neuropsychological, neuroimaging, and CSF biomarker criteria. * Non-Alzheimer neurodegenerative disease (NAD) group: 50 patients with frontotemporal dementia (FTD) or Parkinson's disease (PD) responsive to L-DOPA, negative for AD biomarkers. * Healthy control (HC) group: 50 cognitively normal individuals with normal MRI and neuropsychological profiles. Participants are recruited during routine clinical evaluations or follow-up visits. Healthy controls are recruited through local advertisement within the hospital network. All subjects (or their legal representatives) provide written informed consent prior to participation.
Key inclusion criteria (19 listed)
- Male or female participants aged 50 to 85 years.
- Signed and dated written informed consent (or consent from a legally authorized representative when applicable).
- Clinical diagnosis of Alzheimer's disease with a gradual and progressive decline in memory over at least 6 months.
- Objective evidence of an amnestic syndrome of the hippocampal type (based on RLRI-16, MoCA, or equivalent tests).
- Montreal Cognitive Assessment (MoCA) score between 15 and 23 (inclusive).
Key exclusion criteria (15 listed)
- Neutropenia (neutrophils <1,500/mm³) or thrombocytopenia (platelets <100,000/mm³).
- Education level below primary school.
- History of psychiatric disorders (schizophrenia, psychosis).
- Vascular dementia or mixed dementia.
- Active infectious or chronic inflammatory diseases affecting blood cell function.
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
Diagnostic performance of Aβ and PKC blood biomarkers for Alzheimer's disease detection
Time frame: Immediately after the biological sample collection (single visit per participant).
Quantitative assessment of the sensitivity and specificity of amyloid-β (Aβ) and protein kinase C (PKC) biomarkers measured in stabilized red blood cells using Amoneta's fluorescent microfluidic chip technology. The diagnostic result will be expressed as a binary outcome (Yes/No for Alzheimer's disease) and compared with standard clinical, neuropsychological, neuroimaging, and CSF diagnostic criteria.
2 secondary outcomes
Diagnostic performance of emerging circulating biomarkers for Alzheimer's disease detection
Time frame: Immediately after biological sample collection (single visit per participant).
Comparative analysis between blood-based biomarkers and standard Alzheimer's disease diagnostic tools
Time frame: Immediately after the data analysis following sample collection.
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 29 Dec 2025.
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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.
Jean-François Démonet, MD, PhD principal investigator
Leenaards Memory Center (CLM), Lausanne University Hospital (CHUV)
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's Disease (AD) and Neurodegenerative Disease, run by Amoneta Diagnostics SAS at 1 site in Switzerland.
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 19 inclusion and 15 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 29 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 Switzerland. 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?
Diagnostic performance of Aβ and PKC blood biomarkers for Alzheimer's disease detection (time frame: Immediately after the biological sample collection (single visit per participant).). 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 29 Dec 2025.