Alzheimer's DiseaseADALNCT02557464
Identification of Early Markers of Alzheimer's Disease by Using Eye Tracking in Reading.
A study testing An eye tracking experiment and A neuropsychological evaluation in people with Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The objective of this study is to identify early and accurate semantics markers of Alzheimer's disease (AD) by using two types of methods. First, the investigator will evaluate semantic processing of patients with AD or related disorders which will be compared to age matched controls by taking neuropsychological… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- An eye tracking experiment and A neuropsychological evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2015to 5 Jul 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pour le bras A :
- Mother tongue french participants
- Participants with a level of education = or > to Junior Secondary School Diploma
- Participants with a normal or corrected vision
- Participants with good score at the neuro visual assessments (> or = to 15 at the "detection test" ; > or = to 16 at the "degraded letters" test
- Participants suffering from Alzheimer's or related disorders disease (ICD-10 criteria)
Show all 28Show fewer
- Participants with an MMSE's score between 20 and 27
- Participants must sign the informed consent
- Participants must be affiliated to the social insurance. Non-inclusion criteria
- Impossibility to realize the experiment because of a blurred vision
- History of neurological or psychiatric disease, of alcoholism and of brain injury
- Participants under trusteeship, guardianship or placed under judicial protection
- Persons deprived of their liberty
- Pour le bras B :
- Mother tongue french participants
- Participants with a level of education = or > to Junior Secondary School Diploma
- Participants with a normal or corrected vision
- Participants with no global cognitive impairment with a MMSE's score > or = to 28 and with no difficulty to repeat and recall the 3 words
- Participants with good score at the neuro visual assessments (> or = to 15 at the "detection test" ; > or = to 16 at the "degraded letters" test
- Participants must sign the informed consent
- Participants must be affiliated to the social insurance. Non-inclusion criteria
- Impossibility to realize the experiment because of a blurred vision
- Prescription of psychotropic medication during the week preceding the experiment
- History of neurological or psychiatric disease, of alcoholism and of brain injury
- Evidence of cognitive decline
- Decline in the day-to-day operations
- Participants under trusteeship, guardianship or placed under judicial protection
- Persons deprived of their liberty
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Early Semantic Markers of Alzheimer's Disease by Using Eye Tracking in Reading Neutral and Predictable Sentences
The objective of this study is to identify early and accurate semantics markers of Alzheimer's disease (AD) by using two types of methods. First, the investigator will evaluate semantic processing of patients with AD or related disorders which will be compared to age matched controls by taking neuropsychological tests. Then, the investigator will analyze the effect of contextual word predictability on eye movements in reading sentences with the help of the same participants by using an eye tracker. Both of these methods will be used twice with a time interval of 6 months.
Read the detailed description
Scientific background:
Identifying Alzheimer's disease (AD) as early as possible should enable to propose a re-education platform that would fit the early stage of neuronal loss in this pathology. Neuropsychological evaluations are currently one of the main tools for the early screening of AD. Among the tests proposed during those evaluations, the investigator find the Isaacs Set Test which evaluates the early degradation of semantic memory. Whereas eyes movement behavior during reading is sensitive to semantics factors and allows collecting accurate measurements (as precisely as one millisecond), no study has yet used this technique to precisely identify the precocious semantics troubles of AD.
Goal:
The objective of this study is to identify early and accurate markers of AD by associating semantic neuropsychological assessments and eye tracking during sentences reading.
Method:
The study will include 24 patients with AD or related disorders (Mini Mental State Examination between 20 and 27 ) and 24 age matched controls participants. The experiment will be divided in two steps. First, patients will take a standard neuropsychological evaluation. A specific semantic analysis will be performed on each participant using, for example, the Isaacs Set Test or the Weschler Similarities. The second step will ask the participants to read sentences while an eye tracker (the Eye Link 1000 remote) will record their eyes movements. In order to manipulate semantics factors, each sentence will contain a target word, either predictable or not. The experiment will last one hour and a half. Neuropsychological assessments and eye tracking will be done twice with a time interval of 6 months. The two times will be called T1 and T2 and are required to estimate whether eye tracking is a better predictor of AD than neuropsychological tests or not.
Evaluation criteria:
The eye tracking technique enables to record different sorts of measures. More specifically, the investigator will evaluate gaze duration on the target word. Moreover, neuropsychological tests scores will be collected. It will be, for example, the number of good answers.
Hypothesis and expected results:
First, the investigator expect that the predictability effect on eye movements would be less pronounced for patients with AD or related disorders than for the control group. This effect would be even more diminished at T2. It could be explained by a progressive degradation of the semantic memory of patients. Then, and for the same reasons, the investigator expect that the scores collected from the neuropsychological tests would be pathological for patient suffering from AD or related disorders. The test scores would be even more in deficit at T2. Finally, the investigator predict a correlation between neuropsychological tests data and eye movements data. With an extrapolation, and because eye movements recording allow us to obtain more accurate information about the quality of semantic processes, the investigator formulate the hypothesis that this technique will help to predict earlier AD.
- Conditions
- Alzheimer's Disease
- Being tested
- An eye tracking experiment, A neuropsychological evaluation
- Keywords
- semantic memory, eye movements, reading
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An eye tracking experimentBehavioural
Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months
A neuropsychological evaluationBehavioural
Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease group | Experimental | 24 patients with an Alzheimer's disease or related disorders Receives: Behavioral: An eye tracking experiment; Behavioral: A neuropsychological evaluation |
| control group | Active comparator | 24 age matched controls participants Receives: Behavioral: An eye tracking experiment; Behavioral: A neuropsychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye tracking
Eye tracking (More specifically, the investigator will evaluate gaze duration on target words included in sentences while participant's eye movements will be recorded with the Eye link 1000 remote. Gaze duration is the sum of all fixations on a word prior to moving to another word)
Measured: at six months
Secondary outcomes (7)
The probability that the eyes skip the target word
The Visual Object and Space Perception Battery ( for the "degraded letters" test scores range from 0 to 20 and a score below 16 is considered as pathological; for the "test of detection" scores range from 0 to 20 and a score below 15 is considered as pathological). This test assesses neurovisual capacity
Measured: at six months
the initial landing position of the eye in the target word (in letters)
An eye tracking experiment while participants read sentences on a computer screen
Measured: at six months
the percentage of refixation done on the target word
Measured: at six months
the first fixation duration in the target word
(i.e. the duration of the first fixation on the target word, provided that the word wasn't skipped
Measured: at six months
the single fixation duration
the fixation of the target word when only one fixation is made on that word
Measured: at six months
the percentage of regressive saccade on the target word and the total viewing time
Measured: at six months
Neuropsychological tests scores
Measured: at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start10 Nov 2015
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
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 Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557464
- Sponsor's protocol ID
- 15-AOI-04
- Acronym
- ADAL
- Status last verified
- Nov 2023
- First submitted
- 10 Sep 2015
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Early Semantic Markers of Alzheimer's Disease by Using Eye Tracking in Reading Neutral and Predictable Sentences
- ClinicalTrials.gov ID
- NCT02557464
- Acronym / sponsor ID
- ADAL / 15-AOI-04
- Conditions
- Alzheimer's Disease
- Keywords
- semantic memory, eye movements, reading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 23 Sep 2015 (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.
The objective of this study is to identify early and accurate semantics markers of Alzheimer's disease (AD) by using two types of methods. First, the investigator will evaluate semantic processing of patients with AD or related disorders which will be compared to age matched controls by taking neuropsychological tests. Then, the investigator will analyze the effect of contextual word predictability on eye movements in reading sentences with the help of the same participants by using an eye tracker. Both of these methods will be used twice with a time interval of 6 months.
Detailed description
Scientific background:
Identifying Alzheimer's disease (AD) as early as possible should enable to propose a re-education platform that would fit the early stage of neuronal loss in this pathology. Neuropsychological evaluations are currently one of the main tools for the early screening of AD. Among the tests proposed during those evaluations, the investigator find the Isaacs Set Test which evaluates the early degradation of semantic memory. Whereas eyes movement behavior during reading is sensitive to semantics factors and allows collecting accurate measurements (as precisely as one millisecond), no study has yet used this technique to precisely identify the precocious semantics troubles of AD.
Goal:
The objective of this study is to identify early and accurate markers of AD by associating semantic neuropsychological assessments and eye tracking during sentences reading.
Method:
The study will include 24 patients with AD or related disorders (Mini Mental State Examination between 20 and 27 ) and 24 age matched controls participants. The experiment will be divided in two steps. First, patients will take a standard neuropsychological evaluation. A specific semantic analysis will be performed on each participant using, for example, the Isaacs Set Test or the Weschler Similarities. The second step will ask the participants to read sentences while an eye tracker (the Eye Link 1000 remote) will record their eyes movements. In order to manipulate semantics factors, each sentence will contain a target word, either predictable or not. The experiment will last one hour and a half. Neuropsychological assessments and eye tracking will be done twice with a time interval of 6 months. The two times will be called T1 and T2 and are required to estimate whether eye tracking is a better predictor of AD than neuropsychological tests or not.
Evaluation criteria:
The eye tracking technique enables to record different sorts of measures. More specifically, the investigator will evaluate gaze duration on the target word. Moreover, neuropsychological tests scores will be collected. It will be, for example, the number of good answers.
Hypothesis and expected results:
First, the investigator expect that the predictability effect on eye movements would be less pronounced for patients with AD or related disorders than for the control group. This effect would be even more diminished at T2. It could be explained by a progressive degradation of the semantic memory of patients. Then, and for the same reasons, the investigator expect that the scores collected from the neuropsychological tests would be pathological for patient suffering from AD or related disorders. The test scores would be even more in deficit at T2. Finally, the investigator predict a correlation between neuropsychological tests data and eye movements data. With an extrapolation, and because eye movements recording allow us to obtain more accurate information about the quality of semantic processes, the investigator formulate the hypothesis that this technique will help to predict earlier AD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease group | Experimental | Behavioral: An eye tracking experiment, Behavioral: A neuropsychological evaluation24 patients with an Alzheimer's disease or related disorders |
| control group | Active comparator | Behavioral: An eye tracking experiment, Behavioral: A neuropsychological evaluation24 age matched controls participants |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Mother tongue french participants
- Participants with a level of education = or > to Junior Secondary School Diploma
- Participants with a normal or corrected vision
- Participants with good score at the neuro visual assessments (> or = to 15 at the "detection test" ; > or = to 16 at the "degraded letters" test
- Participants suffering from Alzheimer's or related disorders disease (ICD-10 criteria)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| An eye tracking experimentNeuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months | Behavioural | Alzheimer's disease group, control group |
| A neuropsychological evaluationNeuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months | Behavioural | Alzheimer's disease group, control group |
Primary outcome
Eye tracking
Time frame: at six months
Eye tracking (More specifically, the investigator will evaluate gaze duration on target words included in sentences while participant's eye movements will be recorded with the Eye link 1000 remote. Gaze duration is the sum of all fixations on a word prior to moving to another word)
7 secondary outcomes
The probability that the eyes skip the target word
Time frame: at six months
the initial landing position of the eye in the target word (in letters)
Time frame: at six months
the percentage of refixation done on the target word
Time frame: at six months
the first fixation duration in the target word
Time frame: at six months
the single fixation duration
Time frame: at six months
the percentage of regressive saccade on the target word and the total viewing time
Time frame: at six months
Neuropsychological tests scores
Time frame: at six months
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 14 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An eye tracking experiment and A neuropsychological evaluation in people with Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 1 site 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 28 inclusion and 0 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Eye tracking (time frame: at six months). 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 14 Nov 2023.