- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01555827
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Bordeaux, France, 33000
- CHU bordeaux - Hopital Pellegrin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Contrôler
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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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Expérimental: Maladie d'Alzheimer
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
Délai: inclusion visit (day0)
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inclusion visit (day0)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)
Délai: 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
Délai: 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)
Délai: 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).
Délai: 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)
Délai: inclusion visit (day0)
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inclusion visit (day0)
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Macular and peripheral abnormalities diagnosed in wide-field retinal imaging
Délai: inclusion visit (day0)
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inclusion visit (day0)
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Retinal blood flow velocity (RFI)
Délai: inclusion visit (day0)
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inclusion visit (day0)
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Intraocular pressure
Délai: inclusion visit (day0)
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inclusion visit (day0)
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axial length
Délai: inclusion visit (day 0)
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inclusion visit (day 0)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jean-François KOROBELNIK, Pr, University Hospital, Bordeaux, France
- Chaise d'étude: Delcourt Cécile, Dr, ISPED, bordeaux, France
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Les troubles mentaux
- Troubles neurocognitifs
- Démence
- Tauopathies
- Maladies neurodégénératives
- Maladie d'Alzheimer
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Méthodes épidémiologiques
- Collecte de données
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Santé publique
- Environnement et santé publique
- Enquêtes et questionnaires
Autres numéros d'identification d'étude
- CHUBX2011/19
- 2011-A01219-32 (Autre identifiant: ANSM)
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