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Oculomotor Testing in the Differential Diagnosis of Dementia (OculoMacl)

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ClinicalTrials.gov Identifier: NCT01577394
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Lewy Body Disease Alzheimer's Disease Other: oculomotor measurements Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease
Study Start Date : June 2011
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

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U.S. FDA Resources

Arms and Interventions
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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 Name: reflexive saccades latencies


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method [ Time Frame: at one year ]
    score differences between the two groups

  4. Percentage of alpha synuclein in CSF to discriminate DLB from AD [ Time Frame: at one year ]
    score differences between the two groups

  5. 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

  6. Mean reflexive saccades latency [ Time Frame: at one year ]
    test differences in mean reflexive saccades latency between the two groups

  7. Percentage of express saccades [ Time Frame: at one year ]
    test differences in proportion of express saccades between the two groups

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577394


Locations
France
Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marc Verny, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01577394     History of Changes
Other Study ID Numbers: AOM 09158
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alzheimer disease
Lewy Body Disease
Cognitive Disorders
 Neurodegenerative Diseases
Differential diagnosis
Eye movement

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders