Lewy Body DiseasePhase 3OculoMaclNCT01577394
Oculomotor Testing in the Differential Diagnosis of Dementia
A Phase 3 study testing oculomotor measurements in people with Lewy Body Disease and Alzheimer's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lewy Body Disease, Alzheimer's Disease
- What is being tested?
- oculomotor measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital
Paris, 75013
About this study
Official title: Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease
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
Read the 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.
- Conditions
- Lewy Body Disease, Alzheimer's Disease
- Being tested
- oculomotor measurements
- Keywords
- Alzheimer disease, Lewy Body Disease, Cognitive Disorders, Neurodegenerative Diseases, Differential diagnosis, Eye movement
- Medical subject headings
- Lewy Body Disease, Alzheimer Disease, Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oculomotor measurementsOther
Also called reflexive saccades latencies
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
| Study group | Role | What they receive |
|---|---|---|
| Early stage of dementia | Experimental | oculomotor measurements Receives: Other: oculomotor measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at one year
Secondary outcomes (8)
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.
Measured: at one year
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
Measured: at one year
Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method
score differences between the two groups
Measured: at one year
Percentage of alpha synuclein in CSF to discriminate DLB from AD
score differences between the two groups
Measured: at one year
Variations at one year in oculomotor test scores and neuropsychological test scores
comparing baseline and follow-up performance separately for each group
Measured: at one year
Mean reflexive saccades latency
test differences in mean reflexive saccades latency between the two groups
Measured: at one year
Percentage of express saccades
test differences in proportion of express saccades between the two groups
Measured: at one year
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
Measured: at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Verny, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577394
- Sponsor's protocol ID
- AOM 09158
- Acronym
- OculoMacl
- Status last verified
- Apr 2016
- First submitted
- 23 Feb 2012
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01577394
- Acronym / sponsor ID
- OculoMacl / AOM 09158
- Conditions
- Lewy Body Disease, Alzheimer's Disease
- Keywords
- Alzheimer disease, Lewy Body Disease, Cognitive Disorders, Neurodegenerative Diseases, Differential diagnosis, Eye movement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early stage of dementia | Experimental | Other: oculomotor measurementsoculomotor measurements |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oculomotor measurementsAlso: reflexive saccades latenciesThe 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 | Early stage of dementia |
Primary outcome
Variability of reflexive saccades latencies
Time frame: at one year
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
8 secondary outcomes
Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations
Time frame: at one year
Potential correlations between hippocampal volume and neuropsychological examination in DLB cases
Time frame: at one year
Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method
Time frame: at one year
Percentage of alpha synuclein in CSF to discriminate DLB from AD
Time frame: at one year
Variations at one year in oculomotor test scores and neuropsychological test scores
Time frame: at one year
Mean reflexive saccades latency
Time frame: at one year
Percentage of express saccades
Time frame: at one year
Correlations between neuropsychological tests scores assessing attention abilities and variability of reflexive saccades latencies
Time frame: at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Verny, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oculomotor measurements in people with Lewy Body Disease and Alzheimer's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of reflexive saccades latencies (time frame: at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.