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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04794634
Acronym
RETEVAL
Enrollment
55
Registered
2021-03-12
Start date
2021-01-13
Completion date
2025-12-01
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

DIAGNOSTIC_TESTOptical 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_TESTOptical 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patientsone dayThickness 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 patientsone dayThickness 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 patientsone dayThickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026