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

September 12, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80480
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one day
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.
one day
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.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

June 23, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021_843_0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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