NCT02557464

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

September 10, 2015

Last Update Submit

November 13, 2023

Conditions

Alzheimer's Disease

Keywords

semantic memoryeye movementsreading

Outcome Measures

Primary Outcomes (1)

  • 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)

    at six months

Secondary Outcomes (7)

  • The probability that the eyes skip the target word

    at six months

  • the initial landing position of the eye in the target word (in letters)

    at six months

  • the percentage of refixation done on the target word

    at six months

  • the first fixation duration in the target word

    at six months

  • the single fixation duration

    at six months

  • +2 more secondary outcomes

Study Arms (2)

Alzheimer's disease group

EXPERIMENTAL

24 patients with an Alzheimer's disease or related disorders

Behavioral: An eye tracking experimentBehavioral: A neuropsychological evaluation

control group

ACTIVE COMPARATOR

24 age matched controls participants

Behavioral: An eye tracking experimentBehavioral: A neuropsychological evaluation

Interventions

An eye tracking experimentBEHAVIORAL

Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months

Alzheimer's disease groupcontrol group
A neuropsychological evaluationBEHAVIORAL

Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months

Alzheimer's disease groupcontrol group

Eligibility Criteria

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

You may qualify if:

  • 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)
  • Participants with an MMSE's score between 20 and 27
  • Participants must sign the informed consent
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Claude Pompidou

Nice, 06000, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 23, 2015

Study Start

November 10, 2015

Primary Completion

July 5, 2018

Study Completion

July 5, 2018

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

FR(1)