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NCT05067010: FIREBALZ

Finding Retinal Biomarkers in Alzheimer's Disease

Completed Last updated 8 April 2025
What this trial tests

trial testing Detailed ophthalmologic examination in Alzheimer Disease in 93 participants. Completed in 24 December 2024.

Timeline
10 June 2021
Primary endpoint
23 September 2024
24 December 2024

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
StatusCompleted
Study typeOBSERVATIONAL
Enrollment93
Start date10 June 2021
Primary completion23 September 2024
Estimated completion24 December 2024
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Eligibility, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Retinal manifestations and their diagnostic significance in Alzheimer's disease.
    Abhyankar SD, Little K, Stitt A, Bhatwadekar AD. · · 2025 · PMID 40799319 · DOI 10.1177/25424823251361937

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Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

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Data sources for this page

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