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Identification of Early Markers of Alzheimer's Disease by Using Eye Tracking in Reading. (ADAL)

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
An eye tracking experiment
A neuropsychological evaluation
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring semantic memory, eye movements, reading

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pour le bras A :

Inclusion criteria

  • 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)
  • 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 :

Inclusion criteria

  • 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

Sites / Locations

  • Institut Claude PompidouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alzheimer's disease group

control group

Arm Description

24 patients with an Alzheimer's disease or related disorders

24 age matched controls participants

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
the percentage of refixation done on the target word
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
the single fixation duration
the fixation of the target word when only one fixation is made on that word
the percentage of regressive saccade on the target word and the total viewing time
Neuropsychological tests scores

Full Information

First Posted
September 10, 2015
Last Updated
August 22, 2017
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02557464
Brief Title
Identification of Early Markers of Alzheimer's Disease by Using Eye Tracking in Reading.
Acronym
ADAL
Official Title
Identification of Early Semantic Markers of Alzheimer's Disease by Using Eye Tracking in Reading Neutral and Predictable Sentences
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2015 (Actual)
Primary Completion Date
December 10, 2015 (Actual)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
semantic memory, eye movements, reading

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer's disease group
Arm Type
Experimental
Arm Description
24 patients with an Alzheimer's disease or related disorders
Arm Title
control group
Arm Type
Active Comparator
Arm Description
24 age matched controls participants
Intervention Type
Behavioral
Intervention Name(s)
An eye tracking experiment
Intervention Description
Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months
Intervention Type
Behavioral
Intervention Name(s)
A neuropsychological evaluation
Intervention Description
Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months
Primary Outcome Measure Information:
Title
Eye tracking
Description
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)
Time Frame
at six months
Secondary Outcome Measure Information:
Title
The probability that the eyes skip the target word
Description
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
Time Frame
at six months
Title
the initial landing position of the eye in the target word (in letters)
Description
An eye tracking experiment while participants read sentences on a computer screen
Time Frame
at six months
Title
the percentage of refixation done on the target word
Time Frame
at six months
Title
the first fixation duration in the target word
Description
(i.e. the duration of the first fixation on the target word, provided that the word wasn't skipped
Time Frame
at six months
Title
the single fixation duration
Description
the fixation of the target word when only one fixation is made on that word
Time Frame
at six months
Title
the percentage of regressive saccade on the target word and the total viewing time
Time Frame
at six months
Title
Neuropsychological tests scores
Time Frame
at six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pour le bras A : Inclusion criteria 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) 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 : Inclusion criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip ROBERT, PU-PH
Email
robert.p@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Vanina OLIVERI, CRA
Phone
0033492034254
Email
oliveri.v@chu-nice.fr
Facility Information:
Facility Name
Institut Claude Pompidou
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PU-PH

12. IPD Sharing Statement

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Identification of Early Markers of Alzheimer's Disease by Using Eye Tracking in Reading.

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