Clinical trial NCT02263287: LESCOD: "Lewy Body Screening in Cognitive Disorders"
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
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Lewy Body Disease
Keywords: Alzheimer Disease
Lewy Body Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 133
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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)

Primary outcomes:
measure: Construct validity of the LeSCoD scale with a factorial analysis
timeFrame: Day 0 (during the inclusion visit)
Secondary outcomes:
measure: Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity
timeFrame: Day 0 (During the inclusion visit)
measure: Intergroup variance will be used to assess the quality of the patient denomination
timeFrame: Day 0 (during the inclusion visit)
measure: Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score
timeFrame: Day 0 (during the inclusion visit)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Sarah EVAIN, Doctor
role: STUDY_CHAIR
References: