Alzheimer DiseaseFIREBALZNCT05067010
Finding Retinal Biomarkers in Alzheimer's Disease
An observational study of Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Detailed ophthalmologic examination
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2021to 24 Dec 2024
- How long will I take part?
- 52 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Mémoire de Ressources et de Recherche Paris Nord
Paris, 75010
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Detailed ophthalmologic examination
- Keywords
- Biomarkers
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed ophthalmologic examinationOther
- Visual acuity
- Eye pressure measurement
- Eye crystalline examination
- Fundus examination
- Optical coherence tomography of the retina
- Retinophotos
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic properties of retinal layers thickness measurement using OCT
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.
Measured: up to 6 at 12 weeks
Secondary outcomes (5)
the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of Alzheimer's disease
the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of Alzheimer's disease
Measured: up to 6 at 12 weeks
Relationship between retinal layer thickness measurments and retinal abnormalities
Relationship between retinal layer thickness measurments and retinal abnormalities
Measured: up to 6 at 12 weeks
Relationship between retinal layer thickness measurments and markers of clinical
Relationship between retinal layer thickness measurments and markers of clinical
Measured: up to 6 at 12 weeks
Relationship between retinal layer thickness measurments and imaging severity
Relationship between retinal layer thickness measurments and imaging (hippocampal volume and cortical atrophy evaluated semi-quantitatively on brain MRI) severity
Measured: 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)
the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of cognitive alteration of neurodegenerative origin (all causes)
Measured: up to 6 at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start10 Jun 2021
- Primary completion23 Sep 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
- Target duration
- 52 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COGNAT, Dr, Principal investigator, Cognitive Neurology Center, CMRR Paris Nord Ile-De France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067010
- Sponsor's protocol ID
- D20170821
- Acronym
- FIREBALZ
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Retinal Biomarkers in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05067010
- Acronym / sponsor ID
- FIREBALZ / D20170821
- Conditions
- Alzheimer Disease
- Keywords
- Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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 :
- Contraindication to brain MRI
- Other pathology considered as severe and impairing life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detailed ophthalmologic examination* Visual acuity * Eye pressure measurement * Eye crystalline examination * Fundus examination * Optical coherence tomography of the retina * Retinophotos | Other | – |
Primary outcome
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.
5 secondary outcomes
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
Relationship between retinal layer thickness measurments and retinal abnormalities
Time frame: 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 imaging severity
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)
Time frame: up to 6 at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COGNAT, Dr principal investigator
Cognitive Neurology Center, CMRR Paris Nord Ile-De France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic properties of retinal layers thickness measurement using OCT (time frame: up to 6 at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.