Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers (RETEVAL)

Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Lewy Body Disease; Retina; Optical Coherence Tomography; Cortical Atrophy; Optical Coherence Tomography Angiography; Retinal Thickening; Retinal Nerve Fibres Layer
• Intervention / Treatment: Diagnostic test: Optical coherence tomography (OCT); Diagnostic test: Optical coherence tomograpohy angiography (OCTA)

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients having a consultation in the Research and Resources Memory Center of Amiens (RRMC) ,
• patients registered in the Alzheimer National Bank and having an Alzheimer Disease based on NIA-AA (McKahnn2011)and IWG2 (Dubois et al, 2014) criteria or, having a Lewy body disease based on revised criteria of McKeith et al 2020
• patients having a complete neuropsychological evaluation including a visual inspection time.
• patients having a MMSE ≥ 18/30 so as to ensure a good homogeneity of the group and to have an adequate ocular exam's quality.
• patients having an available MRI in the CHU's database including a 3DT1 sequence
• patients having a visual acuity better than 5/10, spherical refraction of +/- 5D, an astigmatism < 3D and an applanation IOP <22mmHg

Exclusion Criteria:

• Any other neurocognitive disorder
• Any other optical neuropathy including glaucoma
• All kind of retinal disease (diabetic retinopathy, age-related macular degeneration…)
• Diabetes mellitus
• Uncontrolled hypertension blood pressure
• Any ophthalmological conditions interfering with a good ocular examination or OCT quality (cataract, corneal opacity..)
• Severe dementia preventing a good ophthalmological examination
• Not consenting patient
• Patient with guardianship or curatorship having symptoms preventing a good ophthalmological examination (agitation, unstable ocular fixation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alzheimer Disease	Diagnostic test: Optical coherence tomography (OCT); to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects; Diagnostic test: Optical coherence tomograpohy angiography (OCTA); to make a complete ophthalmological and neurological examination, an OCT and OCTA, to AD and to compare their results with LD and controls subjects
Experimental: Lewy body disease	Diagnostic test: Optical coherence tomography (OCT); to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects; Diagnostic test: Optical coherence tomograpohy angiography (OCTA); to make a complete ophthalmological and neurological examination, an OCT and OCTA, to AD and to compare their results with LD and controls subjects
Active Comparator: healthy patient	Diagnostic test: Optical coherence tomography (OCT); to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects; Diagnostic test: Optical coherence tomograpohy angiography (OCTA); to make a complete ophthalmological and neurological examination, an OCT and OCTA, to AD and to compare their results with LD and controls subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patients	Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.	one day
Variation of ganglion cell layer (CGL) thickness in AD patient compared to healthy and LMD patients	Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.	one day
Variation of intern plexiform layer (IPL) thickness in AD patient compared to healthy and LMD patients	Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.	one day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): June 23, 2023
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Retina; Optical coherence tomography; Alzheimer Disease; Optical coherence tomography angiography; Lewy Body Disease; Retinal Thickening; Cortical Atrophy; Retinal Nerve Fibres Layer; Cell Ganglion Layer; Intern Plexiform Layer
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Alzheimer Disease; Lewy Body Disease; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID Numbers: PI2021_843_0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No