LESCOD: "Lewy Body Screening in Cognitive Disorders"

NCT02263287 | Terminated

• 1 other identifier: RC14_0007
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer Disease; Lewy Body Disease

Keywords

Alzheimer Disease; Lewy Body Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0 (during the inclusion visit)

Secondary Outcomes (3)

• Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity

  Day 0 (During the inclusion visit)

• Intergroup variance will be used to assess the quality of the patient denomination

  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

  Day 0 (during the inclusion visit)

Study Arms (3)

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

Other: LeSCoD scale

Dementia with Lewy Bodies (DLB)

OTHER

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

Other: LeSCoD scale

Probable AD and possible DLB

OTHER

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

Other: LeSCoD scale

Interventions

LeSCoD scale OTHER

LeSCoD is a clinical scale

Alzheimer disease (AD); Dementia with Lewy Bodies (DLB); Probable AD and possible DLB

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Sarah EVAIN, Doctor

  Nantes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

FR (1)