Finding Retinal Biomarkers in Alzheimer's Disease (FIREBALZ)

April 4, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Centre Mémoire de Ressources et de Recherche Paris Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients in whom lumbar puncture (LP) is indicated for assessment of CSF AD biomarkers according to French health authority (HAS) 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 (MCI and Dementia) 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 at 12 weeks
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
up to 6 at 12 weeks
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
up to 6 at 12 weeks
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
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)
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)
up to 6 at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Emmanuel COGNAT, Dr, Cognitive Neurology Center, CMRR Paris Nord Ile-De France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Actual)

September 23, 2024

Study Completion (Actual)

December 24, 2024

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D20170821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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