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- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Bordeaux, Francia, 33000
- CHU Bordeaux - Hôpital Pellegrin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Control
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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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Experimental: Enfermedad de 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
Periodo de tiempo: inclusion visit (day0)
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inclusion visit (day0)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: inclusion visit (day0)
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inclusion visit (day0)
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Macular and peripheral abnormalities diagnosed in wide-field retinal imaging
Periodo de tiempo: inclusion visit (day0)
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inclusion visit (day0)
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Retinal blood flow velocity (RFI)
Periodo de tiempo: inclusion visit (day0)
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inclusion visit (day0)
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Intraocular pressure
Periodo de tiempo: inclusion visit (day0)
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inclusion visit (day0)
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axial length
Periodo de tiempo: inclusion visit (day 0)
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inclusion visit (day 0)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean-François KOROBELNIK, Pr, University Hospital, Bordeaux, France
- Silla de estudio: Delcourt Cécile, Dr, ISPED, bordeaux, France
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHUBX2011/19
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Ophthalmological examination & Questionnaire
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