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

Alzheimer Disease Clinical Trial

— RETEVAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794634
• Other study ID #: PI2021_843_0006
• Status: Completed
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 1, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one day
Primary	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.	one day
Primary	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.	one day