Oculomotor Testing in the Differential Diagnosis of Dementia (OculoMacl)

May 20, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease

The aim of this study is to determine whether saccadic eye movement recording may help in the discrimination between Lewy body dementia and Alzheimer disease, in the early stages of the disease.

Study type: Interventional Study design: Intervention Model: Single group assignment Primary purpose: Diagnostic

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dementia with Lewy bodies (DLB) is the second most common cause of neurodegenerative dementia. In its early stages, the differential diagnosis of DLB and Alzheimer's disease (AD) can be challenging. The differential diagnosis is particularly important given that patients with DLB respond well to cholinesterase inhibitors but show sensitivity to neuroleptic medications which are contraindicated in DLB. DLB tends to progress more quickly than Alzheimer's disease. Diagnostic accuracy may be improved. Oculomotor recording, easy to perform could be helpful in order to identify and reliably assess fluctuating attention performance in DLB patients.

Main objective:

- to improve differential diagnosis between DLB and AD in the early stages of the disease with oculomotor measurements

Secondary objectives:

  • to examine the association between the oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations
  • to evaluate the benefit of complementary neuropsychological tests in the distinction between DLB and AD cases
  • to examine the relationship between hippocampal volume and neuropsychological examination in DLB cases
  • to examine the diagnostic performance of MRI (Support Vector Machine) between DLB and AD
  • to examine the interest of CSF alpha synuclein concentration to discriminate DLB from AD
  • to assess at one year variations in oculomotor test scores and neuropsychological test scores Method and design Longitudinal multicenter study including 100 patients with a DLB or AD diagnosis. Clinical examination at one year.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 65 and over
  • Patients with a diagnosis of probable DLB or AD according to the Consortium on DLB criteria (McKeith et al 2005) for Lewy bodies dementia and according to DSM IV and NINCDS- ADRDA criteria for AD or patients in whom there is diagnostic uncertainty between DLB and AD
  • No major sensory deficits
  • MMSE > 20
  • Having signed an informed consent form

Exclusion Criteria:

  • Parkinson syndrome progressing for more than one year regarding cognitive impairment
  • Use of AchEIs medication
  • Taking or having taken anti Parkinson drugs
  • Neuroleptic drugs over the previous three months
  • Contraindication for lumbar puncture (i.e. anticoagulant agents)
  • Patients with Geriatric Depression Scale (GDS) > 10
  • Taking medication that could impact dopamine transporter's measurement
  • Contraindication for MRI examination
  • Diseases involving the short-term survival (shorter than one year)
  • Not fluent in French
  • Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
  • Being under guardianship
  • Absence of caregiver/informant to sign informed consent form
  • Non health insurance affiliation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early stage of dementia
oculomotor measurements
Other: oculomotor measurements

The variability is indicated by the coefficient of variation (i.e. standard-error/mean) of saccades latencies in the gap paradigm.

Mean reflexive saccades latency Percentage of express saccades

Other Names:
  • reflexive saccades latencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variability of reflexive saccades latencies
Time Frame: at one year
The variability is indicated by the coefficient of variation (i.e. standard-error/mean) of saccades latencies in the gap paradigm. The variability and mean latency are expected to be increased while the percentage of express latencies decreased in DLB patients
at one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations
Time Frame: at one year
This indicator concerns the standard Bravais-Pearson correlations between saccades latencies values and scores in neuropsychological tests.
at one year
Potential correlations between hippocampal volume and neuropsychological examination in DLB cases
Time Frame: at one year
This indicator concerns the standard Bravais-Pearson correlations between neuro-psychological test scores and the measures of hippocampal volume
at one year
Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method
Time Frame: at one year
score differences between the two groups
at one year
Percentage of alpha synuclein in CSF to discriminate DLB from AD
Time Frame: at one year
score differences between the two groups
at one year
Variations at one year in oculomotor test scores and neuropsychological test scores
Time Frame: at one year
comparing baseline and follow-up performance separately for each group
at one year
Mean reflexive saccades latency
Time Frame: at one year
test differences in mean reflexive saccades latency between the two groups
at one year
Percentage of express saccades
Time Frame: at one year
test differences in proportion of express saccades between the two groups
at one year
Correlations between neuropsychological tests scores assessing attention abilities and variability of reflexive saccades latencies
Time Frame: at one year
This indicator concerns the standard Bravais-Pearson correlations between attention abilities test scores and the coefficient of variation of reflexive saccades latencies
at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marc Verny, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM 09158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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