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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.


Clinical Trial 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 16.5 months divided into two phases : identification First 60 patients then validation Further 100 patients. Study duration for participants will be 6 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


Related Conditions & MeSH terms


NCT number NCT05067010
Study type Observational [Patient Registry]
Source Assistance Publique - Hôpitaux de Paris
Contact Emmanuel COGNAT, Dr
Phone 01 40 05 49 54
Email [email protected]
Status Recruiting
Phase
Start date June 10, 2021
Completion date February 28, 2023

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