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临床试验/NCT02263287
NCT02263287终止不适用

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"

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
133
试验地点
1
主要终点
Construct validity of the LeSCoD scale with a factorial analysis

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

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

干预措施: LeSCoD scale (Other)

Dementia with Lewy Bodies (DLB)

Other

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

干预措施: LeSCoD scale (Other)

Probable AD and possible DLB

Other

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

干预措施: LeSCoD scale (Other)

结局指标

主要结局

Construct validity of the LeSCoD scale with a factorial analysis

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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LESCOD: "Lewy Body Screening in Cognitive Disorders" | 临床试验