Retinal Neurodegenerative Signs in Alzheimer's Diseases (SIGNAL)
A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Bordeaux, Frankrig, 33000
- CHU bordeaux - Hopital Pellegrin
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Inclusion criteria for AD cases:
- Diagnosis of probable AD, defined according to the NINCDS-ARDRA criteria51
- 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
Inclusion criteria for controls:
- 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:
Exclusion criteria for all patients :
- History of Parkinson's disease or other neurodegenerative disorder
- 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
Additional exclusion criteria for AD cases:
- Dementia of other cause than AD
- Severe AD, defined by MMSE score ≤ 10
Additional exclusion criteria for controls:
- Presence of dementia, of whatever cause
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Styring
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The following examinations will be performed, after pupil dilation:
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:
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Eksperimentel: Alzheimers sygdom
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The following examinations will be performed, after pupil dilation:
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:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Retinal microvascular abnormalities (microaneurysms, micro-hemorrhage, cotton wool spots, arteriovenous nicking), observed on retinal colour photography
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Macular abnormalities observed on retinal colour photographs (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, other retinal diseases)
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Macular abnormalities observed on macular scans in SD-OCT (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, epiretinal membranes, other retinal diseases).
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Macular abnormalities observed in autofluorescence imaging (increased autofluorescence, decreased autofluorescence, reticular drusen, atrophic AMD, other abnormalities)
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Macular and peripheral abnormalities diagnosed in wide-field retinal imaging
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Retinal blood flow velocity (RFI)
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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Intraocular pressure
Tidsramme: inclusion visit (day0)
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inclusion visit (day0)
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axial length
Tidsramme: inclusion visit (day 0)
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inclusion visit (day 0)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jean-François KOROBELNIK, Pr, University Hospital, Bordeaux, France
- Studiestol: Delcourt Cécile, Dr, ISPED, bordeaux, France
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Psykiske lidelser
- Neurokognitive lidelser
- Demens
- Tauopatier
- Neurodegenerative sygdomme
- Alzheimers sygdom
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Undersøgelser og spørgeskemaer
Andre undersøgelses-id-numre
- CHUBX2011/19
- 2011-A01219-32 (Anden identifikator: ANSM)
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