Finding Retinal Biomarkers in Alzheimer's Disease

NCT05067010 | Completed

• 1 other identifier: D20170821
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• the diagnostic properties of optical coherence tomography (OCT) and retinophotos for the diagnosis of Alzheimer's disease

  up to 6 at 12 weeks

• Relationship between retinal layer thickness measurments and retinal abnormalities

  up to 6 at 12 weeks

• Relationship between retinal layer thickness measurments and markers of clinical

  up to 6 at 12 weeks

• Relationship between retinal layer thickness measurments and imaging severity

  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)

  up to 6 at 12 weeks

Interventions

Detailed ophthalmologic examination OTHER

* Visual acuity * Eye pressure measurement * Eye crystalline examination * Fundus examination * Optical coherence tomography of the retina * Retinophotos

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre Mémoire de Ressources et de Recherche Paris Nord

Paris, 75010, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Emmanuel COGNAT, Dr

  Cognitive Neurology Center, CMRR Paris Nord Ile-De France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: October 4, 2021
• Study Start: June 10, 2021
• Primary Completion: September 23, 2024
• Study Completion: December 24, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)