Retinal Neurodegenerative Signs in Alzheimer's Diseases

NCT01555827 | Completed DMC

• 2 other identifiers: CHUBX2011/192011-A01219-32
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Retina; ALzheimer's disease; neurodegenerative signs

Outcome Measures

Primary Outcomes (1)

• RNFL thickness measured on a peri-papillary scan of SD-OCT examination.

  inclusion visit (day0)

Secondary Outcomes (9)

• Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)

  inclusion visit (day0)

• Retinal microvascular abnormalities (microaneurysms, micro-hemorrhage, cotton wool spots, arteriovenous nicking), observed on retinal colour photography

  inclusion visit (day0)

• Macular abnormalities observed on retinal colour photographs (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, other retinal diseases)

  inclusion visit (day0)

• Macular abnormalities observed on macular scans in SD-OCT (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, epiretinal membranes, other retinal diseases).

  inclusion visit (day0)

• Macular abnormalities observed in autofluorescence imaging (increased autofluorescence, decreased autofluorescence, reticular drusen, atrophic AMD, other abnormalities)

  inclusion visit (day0)

Study Arms (2)

Alzheimer Disease

EXPERIMENTAL

Other: Ophthalmological examination & Questionnaire

Control

ACTIVE COMPARATOR

Other: Ophthalmological examination & Questionnaire

Interventions

Ophthalmological examination & Questionnaire OTHER

The following examinations will be performed, after pupil dilation: * Examination with SD-OCT (macular scans, macular volume, peri-papillary scan, retinal autofluorescence, infer-red and red-free imaging) * Colour photographs of the retinal, centered on the macula and on the optic nerve (digital non mydriatic retinal camera) * Wide-field colour and autofluorescence imaging (Optomap) * Measure of intra-ocular pressure (pneumotonometer) 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: * Age, gender * educational level * smoking * cardiovascular diseases, current medications * scores at neuropsychological tests

Alzheimer Disease; Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Dementia of other cause than AD
• Severe AD, defined by MMSE score ≤ 10
• Presence of dementia, of whatever cause

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux - hôpital Pellegrin

Bordeaux, 33000, France

Location

Related Publications (1)

• Saunier V, Merle BMJ, Delyfer MN, Cougnard-Gregoire A, Rougier MB, Amouyel P, Lambert JC, Dartigues JF, Korobelnik JF, Delcourt C. Incidence of and Risk Factors Associated With Age-Related Macular Degeneration: Four-Year Follow-up From the ALIENOR Study. JAMA Ophthalmol. 2018 May 1;136(5):473-481. doi: 10.1001/jamaophthalmol.2018.0504.

  PMID: 29596588 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean-François KOROBELNIK, Pr

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Delcourt Cécile, Dr

  ISPED, bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 15, 2012
• Study Start: March 12, 2012
• Primary Completion: June 7, 2014
• Study Completion: June 7, 2014
• Last Updated: May 14, 2026

Record last verified: 2017-11

Locations

FR (1)