Clinical trial NCT01577394: Oculomotor Testing in the Differential Diagnosis of Dementia
Official title: Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lewy Body Disease
Alzheimer's Disease
Keywords: Alzheimer disease
Lewy Body Disease
Cognitive Disorders
Neurodegenerative Diseases
Differential diagnosis
Eye movement
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Variability of reflexive saccades latencies
timeFrame: at one year
Secondary outcomes:
measure: Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations
timeFrame: at one year
measure: Potential correlations between hippocampal volume and neuropsychological examination in DLB cases
timeFrame: at one year
measure: Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method
timeFrame: at one year
measure: Percentage of alpha synuclein in CSF to discriminate DLB from AD
timeFrame: at one year
measure: Variations at one year in oculomotor test scores and neuropsychological test scores
timeFrame: at one year
measure: Mean reflexive saccades latency
timeFrame: at one year
measure: Percentage of express saccades
timeFrame: at one year
measure: Correlations between neuropsychological tests scores assessing attention abilities and variability of reflexive saccades latencies
timeFrame: at one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marc Verny, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: