" The Eyes Have it " : Ocular Saccade Abnormalities in Prodromal Alzheimer's Disease (LYLO)

This study is currently recruiting participants.
Verified December 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01630525
First received: June 21, 2012
Last updated: December 18, 2013
Last verified: December 2013

June 21, 2012
December 18, 2013
December 2012
May 2014   (final data collection date for primary outcome measure)
Saccades execution parameters [ Time Frame: Study visit (Up to 1 month after inclusion) ] [ Designated as safety issue: No ]

To demonstrate the alteration of saccade execution parameters (latency, velocity, precision, errors) during pro and anti-saccades, spatial decision and prediction tasks in prodromal AD compared to mild to moderate AD and aged-matched controls.

Variables recorded :

Saccades execution parameters :

  • Mean latency (msec),
  • Mean velocity (°/msec) and maximal velocity,
  • Accuracy or mean gain,
  • Mean percent of errors and corrected errors,
  • Mean percent of prediction.
Same as current
Complete list of historical versions of study NCT01630525 on ClinicalTrials.gov Archive Site
  • Neuropsychology tests scores [ Time Frame: At inclusion (Day 0) ] [ Designated as safety issue: No ]
  • Pre-defined variables on visual exploration tasks (fixation number and durations, errors). [ Time Frame: Study visit (Up to 1 month after inclusion) ] [ Designated as safety issue: No ]
  • Number of point fixation in degraded areas and of visual attention induced cards [ Time Frame: Study visit (Up to 1 month after inclusion) ] [ Designated as safety issue: No ]
  • Neuropsychology tests scores [ Time Frame: At inclusion (Day 0) ] [ Designated as safety issue: No ]
  • Pre-defined variables on visual exploration tasks (fixation number and durations, errors). [ Time Frame: Study visit (Up to 1 month after inclusion) ] [ Designated as safety issue: No ]
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" The Eyes Have it " : Ocular Saccade Abnormalities in Prodromal Alzheimer's Disease
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Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been shown to be altered very early, up to 13 years before dementia. This test, as many others executive function tests, requires a fine control of visuomotor coordination. Like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Group A : 30 Prodromal Alzheimer Disease, Group B : 30 typical Alzheimer Disease, Group C : 30 controls age-matched ± 5 years to Group A (to Group A) Total of 90 subjects.

Alzheimer's Disease
  • Other: Neuropsychological assessment
    Neuropsychological assessment : MMSE (Greco), RL/RI-16 items (Van der Linden 2003), visual retention test (DMS48), verbal fluency (Thurstone et Thurstone 1964), TMT A and B (Reitan 1956), DSST (Weschler 1997), Clinical Dementia Rating Scale (Hughes 1982), image naming DO80 (Deloche et Hannequin 1997), Similarities and Digit Span subscores of the WAIS (Weschler 1997), Anxiety and Depression (GDS), activities of daily living (ADL-Katz and IADL-Lawton).
  • Other: ophthalmologic checkup
    Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).
  • Other: Automated non-invasive oculometry
    Automated non-invasive oculometry : 45 minutes with rest periods : horizontal and vertical pro- and anti-saccades, prediction, spatial decision (Monsiman et al. Brain 2005,128:1267-127, items detection (Rösler et al. Cortex 2005 ;41 :512-519) and exploration/curiosity of non congruent images and faces according to Daffner et al. Neurology 1992 ;42 :320-328 and Loughland et al. Biol Psychiatry 2002 ;52 : 338-348).
  • Prodromal AD participants
    Interventions:
    • Other: Neuropsychological assessment
    • Other: ophthalmologic checkup
    • Other: Automated non-invasive oculometry
  • Typical AD participants
    Interventions:
    • Other: Neuropsychological assessment
    • Other: ophthalmologic checkup
    • Other: Automated non-invasive oculometry
  • Control participants
    Interventions:
    • Other: Neuropsychological assessment
    • Other: ophthalmologic checkup
    • Other: Automated non-invasive oculometry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
June 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

All patient groups:

  • Age >60 years
  • Normal vision work-up : (corrected binocular visual acuity > 8/10)
  • Written informed consent
  • Subjects affiliated to Social Security

Group A: Prodromal AD.

  • Memory complaints.
  • Normal or slight restriction of IADL.
  • "hippocampal-type" amnesic syndrome defined by poor free recall despite adequate (and controlled) encoding, decreased total recall because of insufficient effect of cuing or impaired recognition, numerous intrusions (RL/RI-16items)
  • CDR (Clinical Dementia Rating Scale) ≥ 0,5
  • Persistence of memory changes at a subsequent assessment (>3 months)
  • Absence of global cognitive deterioration (MMSE ≥24)
  • Exclusion of other disorders that may cause mild cognitive impairment with adequate tests
  • 1.5 Tesla diagnosis MRI with at least T2, Flair transversal sections and coronal T1 sections in the coronal plan. Absent or slight medio temporal/hippocampal atrophy or if available (non mandatory) characteristic CSF betaA42/tau ratio

Group B: Typical AD (mild to moderate)

  • NINDS-ADRDA diagnosis criteria
  • MMSE ≥ 20

Group C: Control subjects

  • No memory or other significant cognitive complain.
  • MMSE ≥ 24

Exclusion Criteria:

All groups :

  • Clinically significant vision abnormality(P8 without glasses)
  • Oculomotor deficit or strabismus
  • Depression (GDS) with treatment
  • Subjects unable to give their informed consent

Controls :

  • Memory or any other significant cognitive complain.
  • Abnormalities at inclusion (V0) neuropsychology testing suggestive of a cognitive deficit.
Both
60 Years and older
Yes
Contact: TISON François, Pr francois.tison@chu-bordeaux.fr
France
 
NCT01630525
CHUBX 2011/22
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: François TISON, Pr Bordeaux University Hospital
Study Chair: Geneviève CHENE, Pr Bordeaux University Hospital
University Hospital, Bordeaux
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP