A Biomarker-chip Assay in Preserved Red Blood Cells for the Diagnosis of Alzheimer's Disease

NCT07307872 | Completed

• 2 other identifiers: ST00672017-00585
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frontotemporal Dementia (FTD); Alzheimer's Disease (AD); Neurodegenerative Disease; Dementia

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after the biological sample collection (single visit per participant).

Secondary Outcomes (2)

• Diagnostic performance of emerging circulating biomarkers for Alzheimer's disease detection

  Immediately after biological sample collection (single visit per participant).

• Comparative analysis between blood-based biomarkers and standard Alzheimer's disease diagnostic tools

  Immediately after the data analysis following sample collection.

Study Arms (3)

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.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: collaborator
• Leenaards Fondation, Switzerland: collaborator
• Amoneta Diagnostics SAS: lead

Study Sites (1)

Leenaards Memory Center - CHUV

Lausanne, 1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, PBMCs, and urine samples collected for the evaluation of blood-based and circulating biomarkers (Aβ, PKC, proteins, RNA, and metabolomic/lipidomic signatures).

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Dementia; Frontotemporal Dementia; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-François Démonet, MD, PhD

  Leenaards Memory Center (CLM), Lausanne University Hospital (CHUV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 29, 2025
• Study Start: March 23, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CH (1)