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Oculomotor Testing in the Differential Diagnosis of Dementia

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01577394
Acronym
OculoMacl
Enrollment
65
Registered
2012-04-13
Start date
2011-06-30
Completion date
2016-04-30
Last updated
2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Lewy Body Disease

Keywords

Alzheimer disease, Lewy Body Disease, Cognitive Disorders, Neurodegenerative Diseases, Differential diagnosis, Eye movement

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

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.

Interventions

OTHERoculomotor 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Variability of reflexive saccades latenciesat one yearThe 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

MeasureTime frameDescription
Potential correlations between hippocampal volume and neuropsychological examination in DLB casesat one yearThis indicator concerns the standard Bravais-Pearson correlations between neuro-psychological test scores and the measures of hippocampal volume
Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) methodat one yearscore differences between the two groups
Percentage of alpha synuclein in CSF to discriminate DLB from ADat one yearscore differences between the two groups
Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuationsat one yearThis indicator concerns the standard Bravais-Pearson correlations between saccades latencies values and scores in neuropsychological tests.
Mean reflexive saccades latencyat one yeartest differences in mean reflexive saccades latency between the two groups
Percentage of express saccadesat one yeartest differences in proportion of express saccades between the two groups
Correlations between neuropsychological tests scores assessing attention abilities and variability of reflexive saccades latenciesat one yearThis indicator concerns the standard Bravais-Pearson correlations between attention abilities test scores and the coefficient of variation of reflexive saccades latencies
Variations at one year in oculomotor test scores and neuropsychological test scoresat one yearcomparing baseline and follow-up performance separately for each group

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026