Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers (RETEVAL)
Primary Purpose
Optical Coherence Tomography, Optical Coherence Tomography Angiography, Retinal Thickening
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optical coherence tomography (OCT)
Optical coherence tomograpohy angiography (OCTA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Optical Coherence Tomography focused on measuring 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
Eligibility Criteria
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)
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Alzheimer Disease
Lewy body disease
healthy patient
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04794634
First Posted
March 9, 2021
Last Updated
September 12, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04794634
Brief Title
Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers
Acronym
RETEVAL
Official Title
Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer Disease
Arm Type
Experimental
Arm Title
Lewy body disease
Arm Type
Experimental
Arm Title
healthy patient
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical coherence tomography (OCT)
Intervention Description
to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical coherence tomograpohy angiography (OCTA)
Intervention Description
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 Outcome Measure Information:
Title
Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patients
Description
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
Title
Variation of ganglion cell layer (CGL) thickness in AD patient compared to healthy and LMD patients
Description
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
Title
Variation of intern plexiform layer (IPL) thickness in AD patient compared to healthy and LMD patients
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers
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