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Visuospatial Attention, Eye Movements and Instrumental Activities of Daily Living (IADLs) in Alzheimer's Disease (ARVA-MA)

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
visual search performance of everyday objects in realistic scenes
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Control participants

  • Male and female
  • Age between 65 and 75 years old
  • MMSE score equal or > 27
  • Normal visual acuity (with or without correction to normality)
  • Subjects with a score of 0 on " tremors " and " rigidity " items of UPDRS III scale
  • Subjects without major depression criteria according to DSM IV-R
  • No apathy according to diagnostic criteria of apathy
  • Signed informed consent

Inclusion Criteria: Alzheimer's disease patients

  • Male and female
  • Age between 65 and 75 years old
  • Probable diagnosis of Alzheimer's disease with a mild impairment (MMSE 20-26) according to DSM IV diagnosis criteria
  • Normal visual acuity (with or without correction to normality)
  • Subjects with a zero score on " tremors " and " rigidity " items of UPDRS III scale
  • Signed informed consent

Exclusion Criteria:

  • Controls with neurological and/or psychiatric pathologies
  • AD patients with neurological and/or psychiatric pathologies unrelated to AD
  • AD patients with vascular dementia suspicion in addition to the probable diagnosis of AD
  • AD patients with MMSE score < 20
  • Individuals with abnormal visual acuity (i.e., glaucoma, cataract sufficiently severe that limited vision…)
  • Individuals with motor disorders, Parkinsonism…
  • Receiving drug treatments that could alter cognitive functions

Sites / Locations

  • CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alzheimer's patient

Control patient

Arm Description

Probable diagnosis of Alzheimer's disease with a mild impairment (MMSE 20-26) according to DSM IV diagnosis criteria

patient with MMSE score equal or > 27

Outcomes

Primary Outcome Measures

Total number of fixations during search
Oculomotor behavior and search performance in AD patients compared to elderly controls in a computerized visual search task using realistic scenes (Experiment 1), as well as when searching for specific objects in a real setting and during activities of daily living (Experiment 2).
Total duration of fixations during search
This is the eye movement parameters that the investigators will analyze in the data

Secondary Outcome Measures

Full Information

First Posted
May 30, 2016
Last Updated
August 22, 2017
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02941289
Brief Title
Visuospatial Attention, Eye Movements and Instrumental Activities of Daily Living (IADLs) in Alzheimer's Disease
Acronym
ARVA-MA
Official Title
Visuospatial Attention and Eye Movement Behaviour in Patients With Alzheimer's Disease When Searching in Realistic Scenes and a Natural Setting: Exploring Perceptual and Cognitive Mechanisms and Their Relationships With IADLs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2019 (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 aim is to understand which components of attentional deployment and selection are impaired in AD during searching in realistic scenes on a computer screen (Experiment 1) and in a natural setting (Experiment 2).The investigators will also examine how deficits in visual exploration may be related to impairments in semantic, long-term memory (LTM) and working memory (WM) representations by manipulating the semantic consistency between the target and its visual surroundings, and the type of target cue (abstract vs. precise), respectively. Perceptual saliency of target and distractor objects will be also manipulated in Expt.1, In Expt.2, in order to determine how deficits in visual exploration may be involved in the IADL deficits shown by AD patients, participants at each trial will be required to search in a natural settings different types of targets and then to perform an IADL using five objects, among which one of the searched targets. Measures analysed: for the search tasks (Expt. 1 and 2): eye movements in different search phases, accuracy and response times; for IADLs tasks (Expt. 2): eye movements during action planning and execution, motor efficiency (number and types of action performed), time to terminate the activity. Compared to controls, the investigators expect that AD patients will have reduced ability using scene semantic LTM in order to locate the objects, greater attentional capture from highly salient features and greater search performance impairment when higher WM resources are required (abstract target cues). The investigators also expect that their performance at IADLs will be less efficient and, in particular, less organized than control, with reduced advantage of eye guidance.
Detailed Description
It has been well established that visual attention declines early in Alzheimer's Disease (AD). Little is known about visual search in AD, in particular in relation with functional autonomy. The crucial role of the parietal cortex in visuospatial attention and instrumental activities of daily living (IADLs), and the presence of early parietal damage in AD suggest that IADLs may also be impaired early. The aim is to understand which components of attentional deployment and selection are specifically impaired in AD during searching in static realistic scenes presented on a computer screen (Experiment 1) and in a natural setting (Experiment 2: different regions of a room, furnished with different types of objects indicating different possible daily-living environments, like a kitchen or an office). More precisely, the investigators will examine how deficits in visual exploration during search for a target objects may be related to impairments in semantic, long-term memory (LTM) and in working memory (WM) representations by manipulating, respectively, semantic consistency between the target and type of its visual surrounding (scene context, in Expt. 1, or type of co-occurring objects, in Expt 2).and the type of prior information supplied about the target object (abstract - i.e., verbal - or precise, - i.e., pictorial), In Expt. 1 the investigators will also manipulate the perceptual salience (low-level feature: luminance, colour, orientation, etc.) of the target and the distractor objects within the scene. Second, to determine how deficits in visual exploration during search for specific objects may be involved in the deficits of IADL in AD, the investigators will analyse search behaviour in the natural setting, requiring location of three different targets (semantically consistent/related to an IADL, semantically consistent/ non-related to an IADL, semantically inconsistent/non-related). The investigators will required participants to perform an IADL after each search (four trial in total) using, among other four objects, the IADL-related searched target). In Expt. 1 the investigators will test three groups of participants: the AD group (at early stage of the disease), a matched control group of healthy elderly people and a control group of young, healthy individuals. The investigators will examine search performance (accuracy and response time) and oculomotor behaviour during the different search phases (initiation, scene scanning, target verification). They expect that AD patients will have reduced search performance compared to both control groups, which will be also reflected by reduced oculomotor efficiency during the overall search process. Moreover, they hypothesize that patients will be less able to use semantic memory of the type of scene in order to locate the target (reduced benefit of scene consistency), will be strongly disadvantaged in case of higher WM load (abstract target cue) and, finally, will be more influence by perceptual, low-level factors (stronger effect of salience). In Exp. 2, they will test an AD group and a control group of healthy, matched, old controls. With respect to the search tasks, they will analyse the effect of target semantic consistency, target relatedness to IADL and type of target cue (abstract vs. precise). In doing so, they will consider search performance (accuracy and response times) and oculomotor behaviour during search in terms of order and number of object fixated, and duration of their fixation. With respect to the IADLs, they will analyse eye guidance on current action and efficiency of the whole IADL in terms of type and number of actions performed and time to perform the overall activity. They expect that the patterns of eye movements in AD patients will be similar during search and IADLs, with numerous intrusions of distractors and frequent reselections of the same objects. Moreover, they expect that their performance at IADLs will be less efficient than controls, in terms of both action speed and organisation. The use of a natural setting and the analysis of spontaneous oculomotor behavior of patients will improve the ecological validity of research on attentional deficits in AD. This study can also contribute to innovative solutions for diagnosis and treatment, and help research on subjective change in attention and visuospatial function in AD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Alzheimer's patient
Arm Type
Experimental
Arm Description
Probable diagnosis of Alzheimer's disease with a mild impairment (MMSE 20-26) according to DSM IV diagnosis criteria
Arm Title
Control patient
Arm Type
Active Comparator
Arm Description
patient with MMSE score equal or > 27
Intervention Type
Procedure
Intervention Name(s)
visual search performance of everyday objects in realistic scenes
Primary Outcome Measure Information:
Title
Total number of fixations during search
Description
Oculomotor behavior and search performance in AD patients compared to elderly controls in a computerized visual search task using realistic scenes (Experiment 1), as well as when searching for specific objects in a real setting and during activities of daily living (Experiment 2).
Time Frame
at 2 weeks
Title
Total duration of fixations during search
Description
This is the eye movement parameters that the investigators will analyze in the data
Time Frame
at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Control participants Male and female Age between 65 and 75 years old MMSE score equal or > 27 Normal visual acuity (with or without correction to normality) Subjects with a score of 0 on " tremors " and " rigidity " items of UPDRS III scale Subjects without major depression criteria according to DSM IV-R No apathy according to diagnostic criteria of apathy Signed informed consent Inclusion Criteria: Alzheimer's disease patients Male and female Age between 65 and 75 years old Probable diagnosis of Alzheimer's disease with a mild impairment (MMSE 20-26) according to DSM IV diagnosis criteria Normal visual acuity (with or without correction to normality) Subjects with a zero score on " tremors " and " rigidity " items of UPDRS III scale Signed informed consent Exclusion Criteria: Controls with neurological and/or psychiatric pathologies AD patients with neurological and/or psychiatric pathologies unrelated to AD AD patients with vascular dementia suspicion in addition to the probable diagnosis of AD AD patients with MMSE score < 20 Individuals with abnormal visual acuity (i.e., glaucoma, cataract sufficiently severe that limited vision…) Individuals with motor disorders, Parkinsonism… Receiving drug treatments that could alter cognitive functions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanina OLIVERI, Project manager
Phone
0033 4 92 03 42 54
Email
oliveri.v@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanina OLIVERI, project manager
First Name & Middle Initial & Last Name & Degree
Renaud DAVID, PH

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35797174
Citation
Ramzaoui H, Faure S, David R, Spotorno S. Top-down and bottom-up sources of eye-movement guidance during realistic scene search in Alzheimer's disease. Neuropsychology. 2022 Oct;36(7):597-613. doi: 10.1037/neu0000797. Epub 2022 Jul 7.
Results Reference
derived
PubMed Identifier
34124920
Citation
Ramzaoui H, Faure S, Spotorno S. Top-down and bottom-up guidance in normal aging during scene search. Psychol Aging. 2021 Jun;36(4):433-451. doi: 10.1037/pag0000485.
Results Reference
derived

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Visuospatial Attention, Eye Movements and Instrumental Activities of Daily Living (IADLs) in Alzheimer's Disease

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