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临床试验/NCT03698760
NCT03698760已完成不适用

Calibration and Validation of a Computerized Olfactory Test in Subjects With Alzheimer's Disease in a Mild Stage

Jewish General Hospital2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2019年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Objective test of evaluation of the olfactory sensitivity

研究概览

简要总结

This study evaluates the effectiveness of the smell tests that are used in early diagnosis of mild dementia.

详细描述

For twenty years research has shown a strong link between olfactory disorders and Alzheimer's disease. The focus is on the very early alteration of the olfaction which acts as a harbinger of the disease since it is detectable in its asymptomatic phase. In addition, olfactory involvement is a precursor to the transformation of mild cognitive impairment into MA. Indeed the anatomical structures the first lesions are located in the transentorhinal region of the temporal lobe and entorhinal phase, before progressing towards the limbic system, which will mark the clinical appearance of the first signs of AD.

In literature, it has been shown that there was no olfactory test that is recognized as a gold standard in the scientific community due to a lack of homogeneity of the tools used, their availability and their validity depending on the culture. Moreover, of all the tests currently available, none are specific to neurodegenerative diseases.

Very recent studies show that there is also a strong preference for imaging tools or biomarkers in the detection of AD, but it appears that the olfactory disorders are well before these markers. It has been shown that an identification test is comparable in predictive accuracy to neuroimaging and cerebrospinal fluid sampling.

This study will therefore focus on the calibration and validation of a computerized olfactory test for the diagnosis of Alzheimer's disease and based the recommendations of professionals so as to promote the effective use of this test in clinical practice.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 60 years old and over
  • The participants enrolled in the control group must have a score of the Mini-Mental State Exam test greater than or equal to
  • The participants enrolled in the intervention group must have a diagnosis of Alzheimer's disease, and the score of the Mini-Mental State Exam test should be between 20 and 27

排除标准

  • Presenting an unstable, acute or current psychiatric or physical condition that is severe enough to prevent the participant from participating in the study, as determined by the investigator.
  • Having an uncorrected major visual or hearing impairment or anosmia (total olfaction loss).

结局指标

主要结局

Objective test of evaluation of the olfactory sensitivity

时间窗: 15 minutes

olfactory test (only one evaluation): random fragrances, recognition (Yes or No)

次要结局

  • Objective test of evaluation of the olfactory thresholds(15 minutes)
  • Health condition assessed by self-administered questionnaire (SAQ)(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olivier Beauchet

Professor of Geriatrics

Jewish General Hospital

研究点 (2)

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