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Completed

NCT Number: NCT01577394

Oculomotor Testing in the Differential Diagnosis of Dementia

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

Completed

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oculomotor measurements

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: OculoMacl

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 13, 2012
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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