Oculomotor Testing in the Differential Diagnosis of Dementia (OculoMacl)
| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2012 | ||||
| Last Updated Date | October 30, 2012 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01577394 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oculomotor Testing in the Differential Diagnosis of Dementia | ||||
| Official Title ICMJE | Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease | ||||
| 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 |
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| 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: Early stage of dementia
Intervention: Other: oculomotor measurements |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | June 2014 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01577394 | ||||
| Other Study ID Numbers ICMJE | AOM 09158 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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