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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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