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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04794634

Collaborator

(none)

100

Enrollment

Location

Arms

14.8

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Optical Coherence Tomography Optical Coherence Tomography Angiography Retinal Thickening Alzheimer Disease Lewy Body Disease Retina Cortical Atrophy Retinal Nerve Fibres Layer	Diagnostic Test: Optical coherence tomography (OCT) Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 9, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)