Oculomotor Testing in the Differential Diagnosis of Dementia (OculoMacl)
Primary Purpose
Lewy Body Disease, Alzheimer's Disease
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
oculomotor measurements
Sponsored by
About this trial
This is an interventional diagnostic trial for Lewy Body Disease focused on measuring Alzheimer disease, Lewy Body Disease, Cognitive Disorders, Neurodegenerative Diseases, Differential diagnosis, Eye movement
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
Sites / Locations
- Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early stage of dementia
Arm Description
oculomotor measurements
Outcomes
Primary Outcome Measures
Variability of reflexive saccades latencies
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
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
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
score differences between the two groups
Percentage of alpha synuclein in CSF to discriminate DLB from AD
score differences between the two groups
Variations at one year in oculomotor test scores and neuropsychological test scores
comparing baseline and follow-up performance separately for each group
Mean reflexive saccades latency
test differences in mean reflexive saccades latency between the two groups
Percentage of express saccades
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
This indicator concerns the standard Bravais-Pearson correlations between attention abilities test scores and the coefficient of variation of reflexive saccades latencies
Full Information
NCT ID
NCT01577394
First Posted
February 23, 2012
Last Updated
May 20, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01577394
Brief Title
Oculomotor Testing in the Differential Diagnosis of Dementia
Acronym
OculoMacl
Official Title
Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lewy Body Disease, Alzheimer's Disease
Keywords
Alzheimer disease, Lewy Body Disease, Cognitive Disorders, Neurodegenerative Diseases, Differential diagnosis, Eye movement
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early stage of dementia
Arm Type
Experimental
Arm Description
oculomotor measurements
Intervention Type
Other
Intervention Name(s)
oculomotor measurements
Other Intervention Name(s)
reflexive saccades latencies
Intervention Description
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
Primary Outcome Measure Information:
Title
Variability of reflexive saccades latencies
Description
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
Time Frame
at one year
Secondary Outcome Measure Information:
Title
Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations
Description
This indicator concerns the standard Bravais-Pearson correlations between saccades latencies values and scores in neuropsychological tests.
Time Frame
at one year
Title
Potential correlations between hippocampal volume and neuropsychological examination in DLB cases
Description
This indicator concerns the standard Bravais-Pearson correlations between neuro-psychological test scores and the measures of hippocampal volume
Time Frame
at one year
Title
Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method
Description
score differences between the two groups
Time Frame
at one year
Title
Percentage of alpha synuclein in CSF to discriminate DLB from AD
Description
score differences between the two groups
Time Frame
at one year
Title
Variations at one year in oculomotor test scores and neuropsychological test scores
Description
comparing baseline and follow-up performance separately for each group
Time Frame
at one year
Title
Mean reflexive saccades latency
Description
test differences in mean reflexive saccades latency between the two groups
Time Frame
at one year
Title
Percentage of express saccades
Description
test differences in proportion of express saccades between the two groups
Time Frame
at one year
Title
Correlations between neuropsychological tests scores assessing attention abilities and variability of reflexive saccades latencies
Description
This indicator concerns the standard Bravais-Pearson correlations between attention abilities test scores and the coefficient of variation of reflexive saccades latencies
Time Frame
at one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Verny, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Oculomotor Testing in the Differential Diagnosis of Dementia
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