NCT04665622

Brief Summary

Analysis of gaze patterns during social cognition tasks and standardised exploration of a specific artwork, between elderly subjects without cognitive disorders and subjects with neurodegenerative diseases such as Fronto-Temporal Dementia, Alzheimer's Dementia or Parkinson's Disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

March 8, 2017

Last Update Submit

March 8, 2022

Conditions

Alzheimer DementiaParkinson DiseaseFronto-Temporal Dementia

Keywords

Eye-TrackingEmpathySocial cognitionTheory of MindScanpathGaze

Outcome Measures

Primary Outcomes (3)

  • 1. Gaze patterns

    Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in the number of fixation

    baseline

  • 2.Gaze Patterns

    Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in exploration strategy (chronology) on target areas.

    Baseline

  • 3.Gaze Patterns

    Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in time spent on target areas.

    Baseline

Secondary Outcomes (7)

  • Cognitive Theory of mind during an artwork observation: Score 1

    Baseline

  • Cognitive Theory of mind during an artwork observation: Score 2

    Baseline

  • Cognitive Theory of mind: TOM-15 a false-belief task to assess cognitive theory of mind

    Baseline

  • Affective ToM (Score 3)

    Baseline

  • Affective ToM : The Reading the Mind in the Eye test - RME - (Baron-Cohen S at al., 2001)

    Baseline

  • +2 more secondary outcomes

Study Arms (4)

Fronto-temporal Dementia

OTHER

10 subjects

Other: Eye-Tracking / Neuropsychological evaluations

Alzheimer's Dementia

OTHER

20 subjects

Other: Eye-Tracking / Neuropsychological evaluations

Parkinson's Disease

OTHER

20 subjects

Other: Eye-Tracking / Neuropsychological evaluations

Healthy volunteers

OTHER

20 subjects

Other: Eye-Tracking / Neuropsychological evaluations

Interventions

Eye-Tracking / Neuropsychological evaluationsOTHER

Use of Eye-Tracking / Neuropsychological évaluations in 4 groups

Alzheimer's DementiaFronto-temporal DementiaHealthy volunteersParkinson's Disease

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female.
  • years old and above.
  • Sufficient written and oral expression in French.
  • Benefit from French or Monaco Social security.
  • Written informed consent signed by the patient.
  • For the control group: voluntary subjects, without cognitive impairment.
  • For the FTD / AD / PD groups: patients diagnosed with one of these diseases, and volunteers to participate in the study.

You may not qualify if:

  • General anaesthesia within 3 months.
  • Ophthalmological problems preventing a video-oculography examination.
  • Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
  • History of stroke.
  • Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Alzheimer DiseaseParkinson Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A monocentric prospective, descriptive, comparative study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

December 11, 2020

Study Start

April 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)