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

Not Applicable

Completed

• Conditions: Cortical Atrophy; Retinal Nerve Fibres Layer; Retinal Thickening; Lewy Body Disease; Optical Coherence Tomography; Alzheimer Disease; Retina; Optical Coherence Tomography Angiography
• Interventions: Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)

• Registration Number: NCT04794634
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Primary Completion: 2023-06-23
• Status Verified: 2023-09
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lewy body disease	Optical coherence tomography (OCT)	-
healthy patient	Optical coherence tomograpohy angiography (OCTA)	-
Alzheimer Disease	Optical coherence tomograpohy angiography (OCTA)	-
Lewy body disease	Optical coherence tomograpohy angiography (OCTA)	-
Alzheimer Disease	Optical coherence tomography (OCT)	-
healthy patient	Optical coherence tomography (OCT)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France