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Computerized Olfactory Test - Alzheimer Disease Mild Stage

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03698760
Enrollment
82
Registered
2018-10-09
Start date
2019-06-25
Completion date
2020-03-05
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Olfaction Disorders

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTOlfactory 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.

Sponsors

Jewish General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

The study is a single-center controlled study (Jewish General Hospital, Montreal, Quebec, Canada), consisting of two groups of subjects: a control group and a group of subjects with mild Alzheimer's disease.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Objective test of evaluation of the olfactory sensitivity15 minutesolfactory test (only one evaluation): random fragrances, recognition (Yes or No)

Secondary

MeasureTime frameDescription
Health condition assessed by self-administered questionnaire (SAQ)10 minutesself-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty
Objective test of evaluation of the olfactory thresholds15 minutesolfactory test, 6 random fragrances among 14, recognition Yes or No and at what concentration

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026