Minimally invasive detection of early Alzheimer*s disease pathology at the eye clinic using blood tests and eye-scans: the BeyeOMARKER study

Minimally invasive detection of early Alzheimer*s disease pathology at the eye clinic using blood tests and eye-scans: the BeyeOMARKER study - BeyeOMARKER

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56662

Enrollment

700

Registered

2024-03-19

Start date

2024-07-09

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers disease dementia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - >= 50 years of age - No dementia diagnosis

Exclusion criteria

Exclusion criteria: The eye condition only concerns: - A traumatic insult - A superficial inflammatory eye disease (i.e. in cornea and conjunctiva) - A condition in a structure surrounding the eye that is not directly involved in visual processing (e.g. the tear-ducts and eye muscles)

Design outcomes

Primary

Measure	Time frame
The primary parameter of BeyeOMARKER is the predictive value of plasma p-tau and AI-based classification of the HS retinal scan to predict 1) clinical decline (cognitive changes between T0 and T2), and 2) AD pathophysiology (amyloid- and tau-PET visual read).	—

Secondary

Measure	Time frame
Secondary parameters include sociodemographic measures, medical history, blood-based outcomes including existing biomarkers (Aβ40, Aβ42, GFAP, NfL based on the Quanterix N4PE assay) and other existing or emerging biomarkers, standard retinal scan outcomes (e.g. thickness of retinal layers and vascular parameters), HS retinal scan outcomes (e.g. data-driven classification), cognitive and cortical vision performance, structural magnetic resonance imaging (MRI) outcomes (e.g. brain atrophy and neurovascular health), amyloid- and tau-PET (e.g. visual read and quantification), prevalence of PCA, prevalence of plasma p-tau positivity in an eye clinic, and participant experiences.	—

Measure

Time frame

Secondary parameters include sociodemographic measures, medical history, blood-based outcomes including existing biomarkers (Aβ40, Aβ42, GFAP, NfL based on the Quanterix N4PE assay) and other existing or emerging biomarkers, standard retinal scan outcomes (e.g. thickness of retinal layers and vascular parameters), HS retinal scan outcomes (e.g. data-driven classification), cognitive and cortical vision performance, structural magnetic resonance imaging (MRI) outcomes (e.g. brain atrophy and neurovascular health), amyloid- and tau-PET (e.g. visual read and quantification), prevalence of PCA, prevalence of plasma p-tau positivity in an eye clinic, and participant experiences.

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Countries

Netherlands

Outcome results