Alzheimer's DiseaseLYLONCT01630525
" The Eyes Have it " : Ocular Saccade Abnormalities in Prodromal Alzheimer's Disease
An observational study of Alzheimer's Disease, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Neuropsychological assessment, ophthalmologic checkup and Automated non-invasive oculometry
- How many people
- 83 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Lyon UniversityHospital
Lyon, 69500
AP-HM
Marseille, 13385
CHU de Bordeaux Hôpital Haut Lévêque
Pessac, 33604
About this study
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).
- Conditions
- Alzheimer's Disease
- Being tested
- Neuropsychological assessment, ophthalmologic checkup, Automated non-invasive oculometry
- Keywords
- Alzheimer's disease, neurodegenerative signs
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentOther
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 checkupOther
Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).
Automated non-invasive oculometryOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Prodromal AD participants | Not described Receives: Other: Neuropsychological assessment; Other: ophthalmologic checkup; Other: Automated non-invasive oculometry | |
| Typical AD participants | Not described Receives: Other: Neuropsychological assessment; Other: ophthalmologic checkup; Other: Automated non-invasive oculometry | |
| Control participants | Not described Receives: Other: Neuropsychological assessment; Other: ophthalmologic checkup; Other: Automated non-invasive oculometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccades execution parameters
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.
Measured: Study visit (Up to 1 month after inclusion)
Secondary outcomes (3)
Neuropsychology tests scores
Measured: At inclusion (Day 0)
Pre-defined variables on visual exploration tasks (fixation number and durations, errors).
Measured: Study visit (Up to 1 month after inclusion)
Number of point fixation in degraded areas and of visual attention induced cards
Measured: Study visit (Up to 1 month after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François TISON, Pr, Principal investigator, University Hospital, BordeauxGeneviève CHENE, Pr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630525
- Sponsor's protocol ID
- CHUBX 2011/22
- Acronym
- LYLO
- Status last verified
- Jan 2016
- First submitted
- 21 Jun 2012
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " The Eyes Have it " : Ocular Saccade Abnormalities in Prodromal Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01630525
- Acronym / sponsor ID
- LYLO / CHUBX 2011/22
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, neurodegenerative signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prodromal AD participants | – | Other: Neuropsychological assessment, Other: ophthalmologic checkup, Other: Automated non-invasive oculometry |
| Typical AD participants | – | Other: Neuropsychological assessment, Other: ophthalmologic checkup, Other: Automated non-invasive oculometry |
| Control participants | – | Other: Neuropsychological assessment, Other: ophthalmologic checkup, Other: Automated non-invasive oculometry |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (8 listed)
- Clinically significant vision abnormality(P8 without glasses)
- Oculomotor deficit or strabismus
- Depression (GDS) with treatment
- Subjects unable to give their informed consent
- Memory or any other significant cognitive complain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessmentNeuropsychological 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 | Control participants, Prodromal AD participants, Typical AD participants |
| ophthalmologic checkupVision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension). | Other | Control participants, Prodromal AD participants, Typical AD participants |
| Automated non-invasive oculometryAutomated 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). | Other | Control participants, Prodromal AD participants, Typical AD participants |
Primary outcome
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.
3 secondary outcomes
Neuropsychology tests scores
Time frame: At inclusion (Day 0)
Pre-defined variables on visual exploration tasks (fixation number and durations, errors).
Time frame: Study visit (Up to 1 month after inclusion)
Number of point fixation in degraded areas and of visual attention induced cards
Time frame: Study visit (Up to 1 month after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François TISON, Pr principal investigator
University Hospital, Bordeaux
Geneviève CHENE, Pr study chair
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saccades execution parameters (time frame: Study visit (Up to 1 month after inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.