Oculomotor Testing in the Differential Diagnosis of Dementia

Alzheimer's Disease Clinical Trial

— OculoMacl  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577394
• Other study ID #: AOM 09158
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2012
• Last updated: May 20, 2016
• Start date: June 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Lewy Body Disease

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at one year	No
Secondary	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.	at one year	No
Secondary	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	at one year	No
Secondary	Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method	score differences between the two groups	at one year	No
Secondary	Percentage of alpha synuclein in CSF to discriminate DLB from AD	score differences between the two groups	at one year	No
Secondary	Variations at one year in oculomotor test scores and neuropsychological test scores	comparing baseline and follow-up performance separately for each group	at one year	No
Secondary	Mean reflexive saccades latency	test differences in mean reflexive saccades latency between the two groups	at one year	No
Secondary	Percentage of express saccades	test differences in proportion of express saccades between the two groups	at one year	No
Secondary	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	at one year	No