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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Olfaction Disorders
• Intervention / Treatment: Diagnostic test: Olfactory test

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild stage Alzheimer group; Participants with mild stage Alzheimer's disease	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.
Experimental: Control Group; Participants without cognitive disorders	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective test of evaluation of the olfactory sensitivity	olfactory test (only one evaluation): random fragrances, recognition (Yes or No)	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Sensation Disorders; Alzheimer Disease; Olfaction Disorders
• Other Study ID Numbers: 2019-1509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No