Oculomotor Testing in the Differential Diagnosis of Dementia - Full Text View

Purpose

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	Intervention	Phase
Lewy Body Disease Alzheimer's Disease	Other: oculomotor measurements	Phase 3


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease Perry syndrome

MedlinePlus related topics: Alzheimer's Disease Dementia Lewy Body Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Variability of reflexive saccades latencies [ Time Frame: at one year ] [ Designated as safety issue: No ]
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:

Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations [ Time Frame: at one year ] [ Designated as safety issue: No ]
This indicator concerns the standard Bravais-Pearson correlations between saccades latencies values and scores in neuropsychological tests.
Potential correlations between hippocampal volume and neuropsychological examination in DLB cases [ Time Frame: at one year ] [ Designated as safety issue: No ]
This 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) method [ Time Frame: at one year ] [ Designated as safety issue: No ]
score differences between the two groups
Percentage of alpha synuclein in CSF to discriminate DLB from AD [ Time Frame: at one year ] [ Designated as safety issue: No ]
score differences between the two groups
Variations at one year in oculomotor test scores and neuropsychological test scores [ Time Frame: at one year ] [ Designated as safety issue: No ]
comparing baseline and follow-up performance separately for each group
Mean reflexive saccades latency [ Time Frame: at one year ] [ Designated as safety issue: No ]
test differences in mean reflexive saccades latency between the two groups
Percentage of express saccades [ Time Frame: at one year ] [ Designated as safety issue: No ]
test differences in proportion of express saccades between the two groups
Correlations between neuropsychological tests scores assessing attention abilities and variability of reflexive saccades latencies [ Time Frame: at one year ] [ Designated as safety issue: No ]
This indicator concerns the standard Bravais-Pearson correlations between attention abilities test scores and the coefficient of variation of reflexive saccades latencies


Enrollment:	65
Study Start Date:	June 2011
Study Completion Date:	April 2016
Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01577394 History of Changes
Other Study ID Numbers:	AOM 09158
Study First Received:	February 23, 2012
Last Updated:	May 20, 2016
Health Authority:	France: Ministry of Health
Individual Participant Data
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

ClinicalTrials.gov processed this record on September 26, 2016

Oculomotor Testing in the Differential Diagnosis of Dementia (OculoMacl)