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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04794634
Other study ID # PI2021_843_0006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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