Retinal Neurodegenerative Signs in Alzheimer's Diseases
NCT ID: NCT01555827
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2012-03-12
2014-06-07
Brief Summary
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Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.
It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Alzheimer Disease
Ophthalmological examination & Questionnaire
The following examinations will be performed, after pupil dilation:
* Examination with SD-OCT (macular scans, macular volume, peri-papillary scan, retinal autofluorescence, infer-red and red-free imaging)
* Colour photographs of the retinal, centered on the macula and on the optic nerve (digital non mydriatic retinal camera)
* Wide-field colour and autofluorescence imaging (Optomap)
* Measure of intra-ocular pressure (pneumotonometer)
The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:
* Age, gender
* educational level
* smoking
* cardiovascular diseases, current medications
* scores at neuropsychological tests
Control
Ophthalmological examination & Questionnaire
The following examinations will be performed, after pupil dilation:
* Examination with SD-OCT (macular scans, macular volume, peri-papillary scan, retinal autofluorescence, infer-red and red-free imaging)
* Colour photographs of the retinal, centered on the macula and on the optic nerve (digital non mydriatic retinal camera)
* Wide-field colour and autofluorescence imaging (Optomap)
* Measure of intra-ocular pressure (pneumotonometer)
The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:
* Age, gender
* educational level
* smoking
* cardiovascular diseases, current medications
* scores at neuropsychological tests
Interventions
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Ophthalmological examination & Questionnaire
The following examinations will be performed, after pupil dilation:
* Examination with SD-OCT (macular scans, macular volume, peri-papillary scan, retinal autofluorescence, infer-red and red-free imaging)
* Colour photographs of the retinal, centered on the macula and on the optic nerve (digital non mydriatic retinal camera)
* Wide-field colour and autofluorescence imaging (Optomap)
* Measure of intra-ocular pressure (pneumotonometer)
The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:
* Age, gender
* educational level
* smoking
* cardiovascular diseases, current medications
* scores at neuropsychological tests
Eligibility Criteria
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Inclusion Criteria
* Light to moderate severity of the disease, defined by a MMSE score \>10 (global evaluation of cognition)
* Patient aged 50 years or more
* Patient benefiting from social insurance
* Absence of suspicion of dementia, based on normal performance according to age and educational level at neuropsychological testing defined as:
* Free recall ≥17 and total recall ≥40 for the Free and Cued Selective Reminding Test (Grober and Buschke test 52) MMSE ≥ norm for age and educational level (defined by mean - 1 SD)
* Isaac's set test ≥ norm for age and educational level (defined by mean - 1 SD)
* Matched to age and gender of the cases
* Patient benefiting from social insurance
Exclusion Criteria
* History of Horton's disease
* History of inflammatory neuropathies (in particular Devic's disease, multiple sclerosis)
* History of vascular ischemic neuropathies and chronic intracranial hypertension
* History of pituitary tumors
* Presence of diseases (systemic and/or ocular diseases) or behavioural or cognitive symptoms incompatible with eye examination
* Known diabetes
* Person under tutorship or curatorship, person unable to express consent
* Dementia of other cause than AD
* Severe AD, defined by MMSE score ≤ 10
* Presence of dementia, of whatever cause
50 Years
ALL
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Jean-François KOROBELNIK, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux, France
Delcourt Cécile, Dr
Role: STUDY_CHAIR
ISPED, bordeaux, France
Locations
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CHU Bordeaux - hôpital Pellegrin
Bordeaux, , France
Countries
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Other Identifiers
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CHUBX2011/19
Identifier Type: -
Identifier Source: org_study_id