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Trial record 30 of 83 for:    lewy body dementia

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

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ClinicalTrials.gov Identifier: NCT02263287
Recruitment Status : Terminated (recruitment problems)
First Posted : October 13, 2014
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Lewy Body Disease Other: LeSCoD scale Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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"
Actual Study Start Date : October 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017


Arm Intervention/treatment
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
Other: LeSCoD scale
LeSCoD is a clinical scale

Dementia with Lewy Bodies (DLB)
Patients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale
Other: LeSCoD scale
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
Other: LeSCoD scale
LeSCoD is a clinical scale




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263287


Locations
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France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Chair: Sarah EVAIN, Doctor Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02263287     History of Changes
Other Study ID Numbers: RC14_0007
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Nantes University Hospital:
Alzheimer Disease
Lewy Body Disease

Additional relevant MeSH terms:
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Lewy Body Disease
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders