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LESCOD: "Lewy Body Screening in Cognitive Disorders"

NCT ID: NCT02263287

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Alzheimer Disease Lewy Body Disease

Keywords

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Alzheimer Disease Lewy Body Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

LeSCoD scale

Intervention Type OTHER

LeSCoD is a clinical scale

Dementia with Lewy Bodies (DLB)

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

Group Type OTHER

LeSCoD scale

Intervention Type OTHER

LeSCoD is a clinical scale

Probable AD and possible DLB

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

Group Type OTHER

LeSCoD scale

Intervention Type OTHER

LeSCoD is a clinical scale

Interventions

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LeSCoD scale

LeSCoD is a clinical scale

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah EVAIN, Doctor

Role: STUDY_CHAIR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC14_0007

Identifier Type: -

Identifier Source: org_study_id