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Completed

NCT Number: NCT04794634

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

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.

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Key information

Conditions

Optical Coherence Tomography Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cortical Atrophy Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Optical Coherence Tomography Angiography Parkinsonian Disorders Retina Retinal Nerve Fibres Layer Retinal Thickening Synucleinopathies Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Primary outcomes

  1. Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patients

    Time frame: 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.

  2. Variation of ganglion cell layer (CGL) thickness in AD patient compared to healthy and LMD patients

    Time frame: 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.

  3. Variation of intern plexiform layer (IPL) thickness in AD patient compared to healthy and LMD patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: RETEVAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Mar 12, 2021
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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