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

NCT07307872 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-12-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Leenaards Fondation, Switzerland

    collaborator UNKNOWN

  • Amoneta Diagnostics SAS

    lead INDUSTRY

Principal Investigators

  • Jean-François Démonet, MD, PhD · Leenaards Memory Center (CLM), Lausanne University Hospital (CHUV)

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307872 on ClinicalTrials.gov