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Retinal Neurodegenerative Signs in Alzheimer's Diseases (SIGNAL)

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Ophthalmological examination & Questionnaire

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Retina, ALzheimer's disease, neurodegenerative signs

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU Bordeaux - hôpital Pellegrin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alzheimer Disease

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

Macular and peripheral abnormalities diagnosed in wide-field retinal imaging

Retinal blood flow velocity (RFI)

Intraocular pressure

axial length

Full Information

NCT ID

NCT01555827

First Posted

March 14, 2012

Last Updated

November 9, 2017

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT01555827

Brief Title

Retinal Neurodegenerative Signs in Alzheimer's Diseases

Acronym

SIGNAL

Official Title

Retinal Neurodegenerative Signs in Alzheimer's Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

March 12, 2012 (Actual)

Primary Completion Date

June 7, 2014 (Actual)

Study Completion Date

June 7, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Retina, ALzheimer's disease, neurodegenerative signs

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alzheimer Disease

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Ophthalmological examination & Questionnaire

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

inclusion visit (day0)

Secondary Outcome Measure Information:

Title

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

Time Frame

inclusion visit (day0)

Title

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

Time Frame

inclusion visit (day0)

Title

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

Time Frame

inclusion visit (day0)

Title

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

Time Frame

inclusion visit (day0)

Title

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

Time Frame

inclusion visit (day0)

Title

Macular and peripheral abnormalities diagnosed in wide-field retinal imaging

Time Frame

inclusion visit (day0)

Title

Retinal blood flow velocity (RFI)

Time Frame

inclusion visit (day0)

Title

Intraocular pressure

Time Frame

inclusion visit (day0)

Title

axial length

Time Frame

inclusion visit (day 0)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-François KOROBELNIK, Pr

Organizational Affiliation

University Hospital, Bordeaux, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Delcourt Cécile, Dr

Organizational Affiliation

ISPED, bordeaux, France

Official's Role

Study Chair

Facility Information:

Facility Name

CHU Bordeaux - hôpital Pellegrin

City

Bordeaux

ZIP/Postal Code

33000

Country

France

12. IPD Sharing Statement

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Retinal Neurodegenerative Signs in Alzheimer's Diseases

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