Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT01577394
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oculomotor Testing in the Differential Diagnosis of Dementia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OculoMacl
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: