- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630525
" The Eyes Have it " : Ocular Saccade Abnormalities in Prodromal Alzheimer's Disease (LYLO)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Lyon, France, 69500
- Lyon UniversityHospital
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Marseille, France, 13385
- AP-HM
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Pessac, France, 33604
- CHU de Bordeaux Hopital Haut leveque
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control participants
|
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).
Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).
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
|
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).
Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).
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
|
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).
Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saccades execution parameters
Time Frame: Study visit (Up to 1 month after inclusion)
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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 :
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Study visit (Up to 1 month after inclusion)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuropsychology tests scores
Time Frame: At inclusion (Day 0)
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At inclusion (Day 0)
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Pre-defined variables on visual exploration tasks (fixation number and durations, errors).
Time Frame: Study visit (Up to 1 month after inclusion)
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Study visit (Up to 1 month after inclusion)
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Number of point fixation in degraded areas and of visual attention induced cards
Time Frame: Study visit (Up to 1 month after inclusion)
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Study visit (Up to 1 month after inclusion)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Genevieve Chene, Pr, University Hospital, Bordeaux
- Principal Investigator: François TISON, Pr, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2011/22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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