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Completed

NCT Number: NCT01630525

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

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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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lyon UniversityHospital, Lyon, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuropsychological assessment

Other

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).

ophthalmologic checkup

Other

Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).

Automated non-invasive oculometry

Other

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).

Primary outcomes

  1. Saccades execution parameters

    Time frame: Study visit (Up to 1 month after inclusion)

    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.

Secondary outcomes

  1. Neuropsychology tests scores

    Time frame: At inclusion (Day 0)

  2. Pre-defined variables on visual exploration tasks (fixation number and durations, errors).

    Time frame: Study visit (Up to 1 month after inclusion)

  3. Number of point fixation in degraded areas and of visual attention induced cards

    Time frame: Study visit (Up to 1 month after inclusion)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: LYLO

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 28, 2012
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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