NCT05067010Completed
Finding Retinal Biomarkers in Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 8 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 93 (actual)
- First submitted
- 7 Jun 2021
- Start date
- 10 Jun 2021
- Primary completion date
- 23 Sept 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Alzheimer disease
- NCT number
- NCT05067010
What you commit to
- Study type: Observational
- Participants enrolled: 93
- From 10 Jun 2021 to the primary completion date, 23 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Mémoire de Ressources et de Recherche Paris Nord Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.