Oculomotor Testing in the Differential Diagnosis of Dementia (OculoMacl)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Alzheimer's Disease

Lewy Body Disease

Treatments

Other: oculomotor measurements

Study type

Interventional

Funder types

Other

Identifiers

NCT01577394

AOM 09158

Details and patient eligibility

About

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

Full 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.

Enrollment

65 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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