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

About this trial

Last updated 4 months ago

Study ID

ST0067

Status

Completed

Type

Observational

Placebo

Accepting

50 to 85 Years

All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

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 structural MRI (and normal PET scan, if available). * Negative CSF biomarkers (if available).

Exclusion Criteria

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). 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.