Oculomotor Testing in the Differential Diagnosis of Dementia

NCT01577394 | Completed Phase 3

• 1 other identifier: AOM 09158
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Lewy Body Disease; Alzheimer's Disease

Keywords

Alzheimer disease; Lewy Body Disease; Cognitive Disorders; Neurodegenerative Diseases; Differential diagnosis; Eye movement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations

  at one year

• Potential correlations between hippocampal volume and neuropsychological examination in DLB cases

  at one year

• Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method

  at one year

• Percentage of alpha synuclein in CSF to discriminate DLB from AD

  at one year

• Variations at one year in oculomotor test scores and neuropsychological test scores

  at one year

Study Arms (1)

Early stage of dementia

EXPERIMENTAL

oculomotor measurements

Other: oculomotor measurements

Interventions

oculomotor measurements OTHER

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

Also known as: reflexive saccades latencies

Early stage of dementia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Lewy Body Disease; Alzheimer Disease; Cognitive Dysfunction; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurocognitive Disorders; Mental Disorders; Tauopathies; Cognition Disorders

Study Officials

• Marc Verny, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: April 13, 2012
• Study Start: June 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)