Alzheimer DiseaseLESCODNCT02263287
LESCOD: "Lewy Body Screening in Cognitive Disorders"
A study testing LeSCoD scale in people with Alzheimer Disease and Lewy Body Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology registries. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer Disease, Lewy Body Disease
- What is being tested?
- LeSCoD scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Aug 2017
- Phase
- Interventional
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a woman or a male >60 to < 90 years
- Have sufficient visual and auditory acuity
- Be able to speak, read, hear and understand french language
- Be covered by health care insurance
- Have a reliable help/partner/informant/caregiver
- Have a mild to severe cognitive decline based on MMSE (Mini-Mental State Examination) score ( From 18 to 26)
- Give oral agreement to the assessment of the LEsCoD scale during routine consultation
- Have performed neuropsychology tests and MRI respectively within 6 and 12 months
Who cannot join
- Has evidence of neurological or psychiatric disorder other than AD or DLB explaining cognitive decline
- Has received previously or currently neuroleptic treatment
- Has no reliable help/caregiver the day of the visit
- Refuses to give his/her oral agreement to the assessment of the LeSCoD scale
- Has presence on MRI of radiologic evidence of cerebrovascular disease (score Fazekas 2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LESCOD: "A Single Center, Prospective Study Aimed at Validating a Clinical Scale, Screening for Symptoms of Lewy Body Disease in Patients Incipient Dementia of the Alzheimer's and/or Lewy Body Type"
Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value of both diagnostic criteria. To date there is still a need for a tool able to discriminate patients with pure DLB from those expressing common signs with both AD and DLB and those with pure AD. The purpose of this study is to validate a semi quantitative scale designed to reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The investigators hypothesized that the score obtained may differentiate between AD, DLB and patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a preliminary work preceding further studies correlating the LeSCoD score with functional imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an improvement in demented patients' care, as well as a better patient selection for further therapeutic studies
- Conditions
- Alzheimer Disease, Lewy Body Disease
- Being tested
- LeSCoD scale
- Keywords
- Alzheimer Disease, Lewy Body Disease
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeSCoD scaleOther
LeSCoD is a clinical scale
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer disease (AD) | Other | Patients with AD according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria Intervention: LeSCoD scale Receives: Other: LeSCoD scale |
| Dementia with Lewy Bodies (DLB) | Other | Patients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale Receives: Other: LeSCoD scale |
| Probable AD and possible DLB | Other | Patients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale Receives: Other: LeSCoD scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity of the LeSCoD scale with a factorial analysis
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Measured: Day 0 (during the inclusion visit)
Secondary outcomes (3)
Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Measured: Day 0 (During the inclusion visit)
Intergroup variance will be used to assess the quality of the patient denomination
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Measured: Day 0 (during the inclusion visit)
Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Measured: Day 0 (during the inclusion visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah EVAIN, Doctor, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263287
- Sponsor's protocol ID
- RC14_0007
- Acronym
- LESCOD
- Status last verified
- Dec 2017
- First submitted
- 22 Jul 2014
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LESCOD: "A Single Center, Prospective Study Aimed at Validating a Clinical Scale, Screening for Symptoms of Lewy Body Disease in Patients Incipient Dementia of the Alzheimer's and/or Lewy Body Type"
- ClinicalTrials.gov ID
- NCT02263287
- Acronym / sponsor ID
- LESCOD / RC14_0007
- Conditions
- Alzheimer Disease, Lewy Body Disease
- Keywords
- Alzheimer Disease, Lewy Body Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problems
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Oct 2014 (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.
Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value of both diagnostic criteria. To date there is still a need for a tool able to discriminate patients with pure DLB from those expressing common signs with both AD and DLB and those with pure AD. The purpose of this study is to validate a semi quantitative scale designed to reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The investigators hypothesized that the score obtained may differentiate between AD, DLB and patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a preliminary work preceding further studies correlating the LeSCoD score with functional imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an improvement in demented patients' care, as well as a better patient selection for further therapeutic studies
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease (AD) | Other | Other: LeSCoD scalePatients with AD according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria Intervention: LeSCoD scale |
| Dementia with Lewy Bodies (DLB) | Other | Other: LeSCoD scalePatients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale |
| Probable AD and possible DLB | Other | Other: LeSCoD scalePatients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be a woman or a male >60 to < 90 years
- Have sufficient visual and auditory acuity
- Be able to speak, read, hear and understand french language
- Be covered by health care insurance
- Have a reliable help/partner/informant/caregiver
Key exclusion criteria (5 listed)
- Has evidence of neurological or psychiatric disorder other than AD or DLB explaining cognitive decline
- Has received previously or currently neuroleptic treatment
- Has no reliable help/caregiver the day of the visit
- Refuses to give his/her oral agreement to the assessment of the LeSCoD scale
- Has presence on MRI of radiologic evidence of cerebrovascular disease (score Fazekas 2)
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 |
|---|---|---|
| LeSCoD scaleLeSCoD is a clinical scale | Other | Alzheimer disease (AD), Dementia with Lewy Bodies (DLB), Probable AD and possible DLB |
Primary outcome
Construct validity of the LeSCoD scale with a factorial analysis
Time frame: Day 0 (during the inclusion visit)
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
3 secondary outcomes
Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity
Time frame: Day 0 (During the inclusion visit)
Intergroup variance will be used to assess the quality of the patient denomination
Time frame: Day 0 (during the inclusion visit)
Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score
Time frame: Day 0 (during the inclusion visit)
Results and safety
The study was stopped early (reason given: recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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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.
Sarah EVAIN, Doctor study chair
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LeSCoD scale in people with Alzheimer Disease and Lewy Body Disease, run by Nantes University Hospital 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Dec 2017. 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.
Are results available for this study?
The study was stopped early (reason given: recruitment problems). Results are not available in the source record.
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?
Construct validity of the LeSCoD scale with a factorial analysis (time frame: Day 0 (during the inclusion visit)). 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 7 Dec 2017.