A Biomarker-chip Assay in Preserved Red Blood Cells for the Diagnosis of Alzheimer's Disease (NCT07307872) | Clinical Trial Compass
CompletedNot Applicable
A Biomarker-chip Assay in Preserved Red Blood Cells for the Diagnosis of Alzheimer's Disease
Switzerland150 participantsStarted 2017-03-23
Plain-language 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 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.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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).
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic performance of Aβ and PKC blood biomarkers for Alzheimer's disease detection
Timeframe: Immediately after the biological sample collection (single visit per participant).