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Completed

NCT Number: NCT03698760

Computerized Olfactory Test - Alzheimer Disease Mild Stage

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 28.
  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Olfactory test

Diagnostic Test

Olfactory test:

All fragrances tested are kept in an airtight case protected from cold and heat.

The test is done on a tablet and the data will be automatically saved. The first screen is about the administrative data, sex and age of the subject. Olfactory test: six odors among the fourteen are proposed in a randomized way.

Primary outcomes

  1. Objective test of evaluation of the olfactory sensitivity

    Time frame: 15 minutes

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

Secondary outcomes

  1. Health condition assessed by self-administered questionnaire (SAQ)

    Time frame: 10 minutes

    self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty

  2. Objective test of evaluation of the olfactory thresholds

    Time frame: 15 minutes

    olfactory test, 6 random fragrances among 14, recognition Yes or No and at what concentration

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2018
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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