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LESCOD: "Lewy Body Screening in Cognitive Disorders" (LESCOD)

Primary Purpose

Alzheimer Disease, Lewy Body Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LeSCoD scale
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease focused on measuring Alzheimer Disease, Lewy Body Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Alzheimer disease (AD)

Dementia with Lewy Bodies (DLB)

Probable AD and possible DLB

Arm Description

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

Patients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale

Patients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
July 22, 2014
Last Updated
December 5, 2017
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02263287
Brief Title
LESCOD: "Lewy Body Screening in Cognitive Disorders"
Acronym
LESCOD
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"
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
recruitment problems
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Lewy Body Disease
Keywords
Alzheimer Disease, Lewy Body Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer disease (AD)
Arm Type
Other
Arm Description
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
Arm Title
Dementia with Lewy Bodies (DLB)
Arm Type
Other
Arm Description
Patients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale
Arm Title
Probable AD and possible DLB
Arm Type
Other
Arm Description
Patients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale
Intervention Type
Other
Intervention Name(s)
LeSCoD scale
Intervention Description
LeSCoD is a clinical scale
Primary Outcome Measure Information:
Title
Construct validity of the LeSCoD scale with a factorial analysis
Description
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
Time Frame
Day 0 (during the inclusion visit)
Secondary Outcome Measure Information:
Title
Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity
Description
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
Time Frame
Day 0 (During the inclusion visit)
Title
Intergroup variance will be used to assess the quality of the patient denomination
Description
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
Time Frame
Day 0 (during the inclusion visit)
Title
Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score
Description
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
Time Frame
Day 0 (during the inclusion visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah EVAIN, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France

12. IPD Sharing Statement

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LESCOD: "Lewy Body Screening in Cognitive Disorders"

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