- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Bordeaux, Frankrijk, 33000
- CHU bordeaux - Hopital Pellegrin
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Controle
|
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:
|
|
Experimenteel: Ziekte van Alzheimer
|
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:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Retinal microvascular abnormalities (microaneurysms, micro-hemorrhage, cotton wool spots, arteriovenous nicking), observed on retinal colour photography
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular abnormalities observed on retinal colour photographs (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, other retinal diseases)
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular abnormalities observed on macular scans in SD-OCT (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, epiretinal membranes, other retinal diseases).
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular abnormalities observed in autofluorescence imaging (increased autofluorescence, decreased autofluorescence, reticular drusen, atrophic AMD, other abnormalities)
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Macular and peripheral abnormalities diagnosed in wide-field retinal imaging
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Retinal blood flow velocity (RFI)
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
Intraocular pressure
Tijdsspanne: inclusion visit (day0)
|
inclusion visit (day0)
|
|
axial length
Tijdsspanne: inclusion visit (day 0)
|
inclusion visit (day 0)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jean-François KOROBELNIK, Pr, University Hospital, Bordeaux, France
- Studie stoel: Delcourt Cécile, Dr, ISPED, bordeaux, France
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Neurocognitieve stoornissen
- Dementie
- Tauopathieën
- Neurodegeneratieve ziekten
- Ziekte van Alzheimer
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Onderzoekstechnieken
- Epidemiologische methoden
- Gegevensverzameling
- Evaluatiemechanismen voor gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Volksgezondheid
- Milieu en volksgezondheid
- Enquêtes en vragenlijsten
Andere studie-ID-nummers
- CHUBX2011/19
- 2011-A01219-32 (Andere identificatie: ANSM)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .