NCT01630525

Brief Summary

Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been shown to be altered very early, up to 13 years before dementia. This test, as many others executive function tests, requires a fine control of visuomotor coordination. Like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

June 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

3 years

First QC Date

June 21, 2012

Last Update Submit

January 22, 2016

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseaseneurodegenerative signs

Outcome Measures

Primary Outcomes (1)

  • Saccades execution parameters

    To demonstrate the alteration of saccade execution parameters (latency, velocity, precision, errors) during pro and anti-saccades, spatial decision and prediction tasks in prodromal AD compared to mild to moderate AD and aged-matched controls. Variables recorded : Saccades execution parameters : * Mean latency (msec), * Mean velocity (°/msec) and maximal velocity, * Accuracy or mean gain, * Mean percent of errors and corrected errors, * Mean percent of prediction.

    Study visit (Up to 1 month after inclusion)

Secondary Outcomes (3)

  • Neuropsychology tests scores

    At inclusion (Day 0)

  • Pre-defined variables on visual exploration tasks (fixation number and durations, errors).

    Study visit (Up to 1 month after inclusion)

  • Number of point fixation in degraded areas and of visual attention induced cards

    Study visit (Up to 1 month after inclusion)

Study Arms (3)

Prodromal AD participants

Other: Neuropsychological assessmentOther: ophthalmologic checkupOther: Automated non-invasive oculometry

Typical AD participants

Other: Neuropsychological assessmentOther: ophthalmologic checkupOther: Automated non-invasive oculometry

Control participants

Other: Neuropsychological assessmentOther: ophthalmologic checkupOther: Automated non-invasive oculometry

Interventions

Neuropsychological assessmentOTHER

Neuropsychological assessment : MMSE (Greco), RL/RI-16 items (Van der Linden 2003), visual retention test (DMS48), verbal fluency (Thurstone et Thurstone 1964), TMT A and B (Reitan 1956), DSST (Weschler 1997), Clinical Dementia Rating Scale (Hughes 1982), image naming DO80 (Deloche et Hannequin 1997), Similarities and Digit Span subscores of the WAIS (Weschler 1997), Anxiety and Depression (GDS), activities of daily living (ADL-Katz and IADL-Lawton).

Control participantsProdromal AD participantsTypical AD participants
ophthalmologic checkupOTHER

Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).

Control participantsProdromal AD participantsTypical AD participants
Automated non-invasive oculometryOTHER

Automated non-invasive oculometry : 45 minutes with rest periods : horizontal and vertical pro- and anti-saccades, prediction, spatial decision (Monsiman et al. Brain 2005,128:1267-127, items detection (Rösler et al. Cortex 2005 ;41 :512-519) and exploration/curiosity of non congruent images and faces according to Daffner et al. Neurology 1992 ;42 :320-328 and Loughland et al. Biol Psychiatry 2002 ;52 : 338-348).

Control participantsProdromal AD participantsTypical AD participants

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Group A : 30 Prodromal Alzheimer Disease, Group B : 30 typical Alzheimer Disease, Group C : 30 controls age-matched ± 5 years to Group A (to Group A) Total of 90 subjects.

You may qualify if:

  • All patient groups:
  • Age \>60 years
  • Normal vision work-up : (corrected binocular visual acuity \> 8/10)
  • Written informed consent
  • Subjects affiliated to Social Security
  • Group A: Prodromal AD.
  • Memory complaints.
  • Normal or slight restriction of IADL.
  • "hippocampal-type" amnesic syndrome defined by poor free recall despite adequate (and controlled) encoding, decreased total recall because of insufficient effect of cuing or impaired recognition, numerous intrusions (RL/RI-16items)
  • CDR (Clinical Dementia Rating Scale) ≥ 0,5
  • Persistence of memory changes at a subsequent assessment (\>3 months)
  • Absence of global cognitive deterioration (MMSE ≥24)
  • Tesla diagnosis MRI with at least T2, Flair transversal sections and coronal T1 sections in the coronal plan. Absent or slight medio temporal/hippocampal atrophy or if available (non mandatory) characteristic CSF betaA42/tau ratio
  • Group B: Typical AD (mild to moderate)
  • NINDS-ADRDA diagnosis criteria
  • +4 more criteria

You may not qualify if:

  • All groups :
  • Clinically significant vision abnormality(P8 without glasses)
  • Oculomotor deficit or strabismus
  • Depression (GDS) with treatment
  • Subjects unable to give their informed consent
  • Controls :
  • Memory or any other significant cognitive complain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lyon UniversityHospital

Lyon, 69500, France

Location

AP-HM

Marseille, 13385, France

Location

CHU de Bordeaux Hôpital Haut Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • François TISON, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Geneviève CHENE, Pr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 28, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

FR(3)