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

NCT04794634 | Completed

• 1 other identifier: PI2021_843_0006
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Optical Coherence Tomography; Optical Coherence Tomography Angiography; Retinal Thickening; Alzheimer Disease; Lewy Body Disease; Retina; Cortical Atrophy; Retinal Nerve Fibres Layer

Keywords

Optical coherence tomography; Optical coherence tomography angiography; Retinal Thickening; Alzheimer Disease; Lewy Body Disease; Retina; Cortical Atrophy; Retinal Nerve Fibres Layer; Cell Ganglion Layer; Intern Plexiform Layer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Alzheimer Disease

EXPERIMENTAL

Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)

Lewy body disease

EXPERIMENTAL

Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)

healthy patient

ACTIVE COMPARATOR

Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)

Interventions

Optical coherence tomography (OCT) DIAGNOSTIC_TEST

to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects

Alzheimer Disease; Lewy body disease; healthy patient

Optical coherence tomograpohy angiography (OCTA) DIAGNOSTIC_TEST

to make a complete ophthalmological and neurological examination, an OCT and OCTA, to AD and to compare their results with LD and controls subjects

Alzheimer Disease; Lewy body disease; healthy patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: January 13, 2021
• Primary Completion: June 23, 2023
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)