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

NCT ID: NCT04794634

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2025-12-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Alzheimer Disease

Group Type: EXPERIMENTAL

Optical coherence tomography (OCT)

Intervention Type: DIAGNOSTIC_TEST

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

Optical coherence tomograpohy angiography (OCTA)

Intervention Type: 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

Lewy body disease

Group Type: EXPERIMENTAL

Optical coherence tomography (OCT)

Intervention Type: DIAGNOSTIC_TEST

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

Optical coherence tomograpohy angiography (OCTA)

Intervention Type: 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

healthy patient

Group Type: ACTIVE_COMPARATOR

Optical coherence tomography (OCT)

Intervention Type: DIAGNOSTIC_TEST

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

Optical coherence tomograpohy angiography (OCTA)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Countries

France

Other Identifiers

PI2021_843_0006

Identifier Type: -

Identifier Source: org_study_id