Clinical trial NCT01555827: Retinal Neurodegenerative Signs in Alzheimer's Diseases
Official title: Retinal Neurodegenerative Signs in Alzheimer's Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Retina
ALzheimer's disease
neurodegenerative signs
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
timeFrame: inclusion visit (day0)
Secondary outcomes:
measure: Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)
timeFrame: inclusion visit (day0)
measure: Retinal microvascular abnormalities (microaneurysms, micro-hemorrhage, cotton wool spots, arteriovenous nicking), observed on retinal colour photography
timeFrame: inclusion visit (day0)
measure: Macular abnormalities observed on retinal colour photographs (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, other retinal diseases)
timeFrame: inclusion visit (day0)
measure: Macular abnormalities observed on macular scans in SD-OCT (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, epiretinal membranes, other retinal diseases).
timeFrame: inclusion visit (day0)
measure: Macular abnormalities observed in autofluorescence imaging (increased autofluorescence, decreased autofluorescence, reticular drusen, atrophic AMD, other abnormalities)
timeFrame: inclusion visit (day0)
measure: Macular and peripheral abnormalities diagnosed in wide-field retinal imaging
timeFrame: inclusion visit (day0)
measure: Retinal blood flow velocity (RFI)
timeFrame: inclusion visit (day0)
measure: Intraocular pressure
timeFrame: inclusion visit (day0)
measure: axial length
timeFrame: inclusion visit (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - hôpital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux, France
name: Jean-François KOROBELNIK, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: ISPED, bordeaux, France
name: Delcourt Cécile, Dr
role: STUDY_CHAIR
References: