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NCT04794634Completed

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

Source: ClinicalTrials.gov · Last updated 8 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
55 (actual)
First submitted
9 Mar 2021
Start date
13 Jan 2021
Primary completion date
23 Jun 2023
Lead sponsor
Centre Hospitalier Universitaire, Amiens
NCT number
NCT04794634

What you commit to

  • Study type: Interventional
  • Participants enrolled: 55
  • From 13 Jan 2021 to the primary completion date, 23 Jun 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any other neurocognitive disorder
  • 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

Age

  • All kind of retinal disease (diabetic retinopathy, age-related macular degeneration…)

Other

  • Any other optical neuropathy including glaucoma
  • Not consenting patient
  • Patient with guardianship or curatorship having symptoms preventing a good ophthalmological examination (agitation, unstable ocular fixation)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
Coordinator of this site? Confirm its status
AmiensFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.