Computerized Olfactory Test - Alzheimer Disease Mild Stage

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698760
• Other study ID #: 2019-1509
• Status: Completed
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: July 2020
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Olfaction Disorders

Intervention

Diagnostic Test:
• Olfactory 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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective test of evaluation of the olfactory sensitivity	olfactory test (only one evaluation): random fragrances, recognition (Yes or No)	15 minutes
Secondary	Health condition assessed by self-administered questionnaire (SAQ)	self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty	10 minutes
Secondary	Objective test of evaluation of the olfactory thresholds	olfactory test, 6 random fragrances among 14, recognition Yes or No and at what concentration	15 minutes