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CompletedNCT04794634RETEVALUpdated Dec 8, 2025

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

An interventional study of Optical coherence tomography (OCT) and Optical coherence tomograpohy angiography (OCTA) in Optical Coherence Tomography, Optical Coherence Tomography Angiography and Retinal Thickening, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

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
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 55 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Alzheimer Disease

    Diagnostic Test: Optical coherence tomography (OCT) · Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)

  • Experimental
    Lewy body disease

    Diagnostic Test: Optical coherence tomography (OCT) · Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)

  • Active comparator
    healthy patient

    Diagnostic Test: Optical coherence tomography (OCT) · Diagnostic Test: Optical coherence tomograpohy angiography (OCTA)

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

06

What researchers measure

Primary outcomes

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

    Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.

    Time frame: one day

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

    Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.

    Time frame: one day

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

    Thickness of retinal nerve fibres layer (RNFL), ganglion cell layer (CGL), intern plexiform layer (IPL) within the macular zone of patients suffering from AD.

    Time frame: one day

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80480, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04794634
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Mar 12, 2021
Start date
Jan 13, 2021
Primary completion
Jun 23, 2023
Completion
Dec 1, 2025
Last update
Dec 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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