Finding Retinal Biomarkers in Alzheimer's Disease

Alzheimer Disease Clinical Trial

— FIREBALZ  

Official title:

Finding Retinal Biomarkers in Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067010
• Other study ID #: D20170821
• Status: Recruiting
• Start date: June 10, 2021
• Est. completion date: December 24, 2024

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Emmanuel COGNAT, Dr
• Phone: 01 40 05 49 54
• Email: emmanuel.cognat[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 24, 2024
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
France	Centre Mémoire de Ressources et de Recherche Paris Nord	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 6 at 12 weeks
Secondary	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	up to 6 at 12 weeks
Secondary	Relationship between retinal layer thickness measurments and retinal abnormalities	Relationship between retinal layer thickness measurments and retinal abnormalities	up to 6 at 12 weeks
Secondary	Relationship between retinal layer thickness measurments and markers of clinical	Relationship between retinal layer thickness measurments and markers of clinical	up to 6 at 12 weeks
Secondary	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	up to 6 at 12 weeks
Secondary	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)	up to 6 at 12 weeks