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Completed

NCT Number: NCT05067010

Finding Retinal Biomarkers in Alzheimer's Disease

CSF Alzheimer's disease (AD) biomarkers are the only one that reflect both Aβ and tau pathologies. There is increasing evidence for the presence of AD abnormalities in the retina of AD patients. Recent studies showed that they can be detected in living patients. Thus, retinal AD-linked abnormalities might be used as alternative diagnostic biomarkers for AD.

FIREBALZ study aims at identifying and validating retinal biomarkers for the diagnosis of Alzheimer's disease.

The study will include 160 patients in whom LP is indicated for assessment of CSF AD biomarkers according to French health authority (HAS) recommendations. Those patients will undergo a detailed neuro-ophtalmologic evaluation including retinal layers thickness evaluation (optical coherence tomography).

Univariate and multivariate analyses will be performed to test diagnostic properties of retinal parameters as compared to current diagnostic criteria including CSF biomarkers and logistic regression models will be used.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Mémoire de Ressources et de Recherche Paris Nord

Paris, 75010, France

About this study

Cerebrospinal fluid (CSF) Alzheimer's disease (AD) biomarkers are the only one that reflect both Aβ and tau pathologies. There is increasing evidence for the presence of AD abnormalities in the retina of AD patients. Recent studies showed that they can be detected in living patients. Thus, retinal AD-linked abnormalities might be used as alternative diagnostic biomarkers for AD.

FIREBALZ study aims at identifying and validating retinal biomarkers for the diagnosis of Alzheimer's disease.

The study will include 160 patients in whom lumbar puncture is indicated for assessment of CSF AD biomarkers according to French health authority recommendations. All patients will be recruited in the Cognitive Neurology Center (CMRR Paris Nord Ile-De-France), Paris, France. Patients will undergo a detailed neuro-ophtalmologic evaluation including complete ophthalmologic work-up to rule out chronic retinal pathology and retinal layers thickness evaluation (optical coherence tomography).

Inclusion period will be 40.5 months, Study duration for participants will be 6 at 12 weeks.

Two groups of patients will be defined for comparison according to LP results : patients with AD according to McKhann 2011 criteria and patients without AD Univariate and multivariate analyses will be performed to test diagnostic properties of retinal parameters and logistic regression models will be used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient managed at the cognitive neurology center for cognitive impairment with a defined LP indication for the assessment of CSF AD biomarkers according to French National Health Agency recommandations in a clinical practice setting
  • Patients with National Health Insurance coverage
  • Patients willing to participate to the research and sign informed consent

Exclusion criteria

  • Patient refusing to participate to research or unable to sign informed consent
  • Patients without indication or displaying contraindication of LP
  • Chronic retinal pathology interfering with analysis :
  • chronic glaucoma
  • diabetic retinopathy
  • severe hypertensive retinopathy
  • Contraindication to brain MRI
  • Other pathology considered as severe and impairing life expectancy

Treatment and study plan

Detailed ophthalmologic examination

Other
  • Visual acuity
  • Eye pressure measurement
  • Eye crystalline examination
  • Fundus examination
  • Optical coherence tomography of the retina
  • Retinophotos

Primary outcomes

  1. Diagnostic properties of retinal layers thickness measurement using OCT

    Time frame: up to 6 at 12 weeks

    Diagnostic properties of retinal layers thickness measurement using OCT for the diagnosis of probable AD according to McKahnn 2011 criteria combining clinical criteria and CSF biomarkers results.

Secondary outcomes

  1. the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of Alzheimer's disease

    Time frame: up to 6 at 12 weeks

    the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of Alzheimer's disease

  2. Relationship between retinal layer thickness measurments and retinal abnormalities

    Time frame: up to 6 at 12 weeks

    Relationship between retinal layer thickness measurments and retinal abnormalities

  3. Relationship between retinal layer thickness measurments and markers of clinical

    Time frame: up to 6 at 12 weeks

    Relationship between retinal layer thickness measurments and markers of clinical

  4. Relationship between retinal layer thickness measurments and imaging severity

    Time frame: up to 6 at 12 weeks

    Relationship between retinal layer thickness measurments and imaging (hippocampal volume and cortical atrophy evaluated semi-quantitatively on brain MRI) severity

  5. the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of cognitive alteration of neurodegenerative origin (all causes)

    Time frame: up to 6 at 12 weeks

    the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of cognitive alteration of neurodegenerative origin (all causes)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: FIREBALZ

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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