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Trial record 3 of 3 for:    Linden depression

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01630525
First received: June 21, 2012
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Alzheimer's Disease
Other: Neuropsychological assessment
Other: ophthalmologic checkup
Other: Automated non-invasive oculometry

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prodromal AD participants 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).
Typical AD participants 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).
Control participants 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).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630525

Contacts
Contact: TISON François, Pr francois.tison@chu-bordeaux.fr

Locations
France
Lyon UniversityHospital Recruiting
Lyon, France, 69500
Contact: alain VIGHETTO, Pr       alain.vighetto@chu-lyon.fr   
Principal Investigator: Alain VIGHETTO, Pr         
AP-HM Recruiting
Marseille, France, 13385
Contact: Mathieu CECCALDI, Pr         
Principal Investigator: Mathieu CECCALDI, Pr         
CHU de Bordeaux Hôpital Haut Lévêque Recruiting
Pessac, France, 33604
Contact: François Tison, Pr       francois.tison@chu-bordeaux.fr   
Principal Investigator: François TISON, Pr         
Sub-Investigator: Jean-François DARTIGUES, Pr         
Sub-Investigator: Hélène AMIEVA, Dr         
Sub-Investigator: Marie-Bénédicte ROUGIER, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: François TISON, Pr Bordeaux University Hospital
Study Chair: Geneviève CHENE, Pr Bordeaux University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01630525     History of Changes
Other Study ID Numbers: CHUBX 2011/22
Study First Received: June 21, 2012
Last Updated: July 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Alzheimer's disease
neurodegenerative signs

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014