- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02263287
LESCOD: "Lewy Body Screening in Cognitive Disorders" (LESCOD)
December 5, 2017 updated by: Nantes University Hospital
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nantes, France
- Nantes University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Alzheimer disease (AD)
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
|
LeSCoD is a clinical scale
|
Other: Dementia with Lewy Bodies (DLB)
Patients with probable DLB according to McKeith criteria.
Intervention: LeSCoD scale
|
LeSCoD is a clinical scale
|
Other: Probable AD and possible DLB
Patients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale
|
LeSCoD is a clinical scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0 (during the inclusion visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity
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
|
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)
|
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
|
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)
|
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
|
Day 0 (during the inclusion visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sarah EVAIN, Doctor, Nantes University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
July 22, 2014
First Submitted That Met QC Criteria
October 8, 2014
First Posted (Estimate)
October 13, 2014
Study Record Updates
Last Update Posted (Actual)
December 7, 2017
Last Update Submitted That Met QC Criteria
December 5, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC14_0007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on LeSCoD scale
-
Hospices Civils de LyonRecruitingChild Psychiatry | Adolescent PsychiatryFrance
-
GCS Ramsay Santé pour l'Enseignement et la RechercheCompletedComplex Post-Traumatic Stress DisorderFrance
-
Jonathan PearlmanCompleted
-
Nanjing Medical UniversityCompleted
-
Pole Santé Plouasne Saint Pern BecherelCompletedFrail Elderly | Locomotor Activity | Functionally-Impaired ElderlyFrance
-
Assiut UniversityUnknownPatients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed DiagnosisEgypt
-
Istanbul Medipol University HospitalCompletedPain | Dental PainTurkey
-
Rambam Health Care CampusUnknownStress Disorders, Post-Traumatic | Depressive Disorder, MajorIsrael
-
Konya Beyhekim Training and Research HospitalRecruiting
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Terminated